Trial Outcomes & Findings for BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis (NCT NCT02719171)
NCT ID: NCT02719171
Last Updated: 2019-05-30
Results Overview
Response defined by ACR20 criteria (improvement from baseline) at Week 16: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient assessment of pain * Patient global assessment of disease activity * Investigator's global assessment of disease activity * Health Assessment Questionnaire Disability Index (HAQ-DI) * Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
Week 16
Results posted on
2019-05-30
Participant Flow
This study included a 6-week screening period.
Participant milestones
| Measure |
Placebo
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
42
|
39
|
20
|
|
Overall Study
COMPLETED
|
41
|
38
|
39
|
37
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
3
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Subject Withdrawal
|
0
|
2
|
2
|
1
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Placebo
n=42 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=42 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=42 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=39 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=20 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.0 years
STANDARD_DEVIATION 11.16 • n=5 Participants
|
51.8 years
STANDARD_DEVIATION 14.56 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 12.33 • n=5 Participants
|
51.6 years
STANDARD_DEVIATION 11.87 • n=4 Participants
|
53.8 years
STANDARD_DEVIATION 10.98 • n=21 Participants
|
51.0 years
STANDARD_DEVIATION 12.35 • n=8 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
80 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
105 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
177 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
157 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Week 16Population: FAS
Response defined by ACR20 criteria (improvement from baseline) at Week 16: ≥ 20% improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% improvement in at least 3 of the 5 following parameters: * Patient assessment of pain * Patient global assessment of disease activity * Investigator's global assessment of disease activity * Health Assessment Questionnaire Disability Index (HAQ-DI) * Acute phase reactant value (C-reactive protein). Nonresponder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=42 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=42 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=39 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=20 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=84 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=81 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 16
|
35.7 percentage of participants
Interval 23.5 to 49.5
|
57.1 percentage of participants
Interval 43.3 to 70.2
|
61.9 percentage of participants
Interval 48.0 to 74.4
|
59.0 percentage of participants
Interval 44.6 to 72.3
|
65.0 percentage of participants
Interval 44.2 to 82.3
|
59.5 percentage of participants
Interval 50.0 to 68.6
|
60.5 percentage of participants
Interval 50.8 to 69.6
|
SECONDARY outcome
Timeframe: Week 16Population: FAS
Response defined by ACR50 criteria (improvement from baseline) at Week 16: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% improvement in at least 3 of the 5 following parameters: * Patient assessment of pain * Patient global assessment of disease activity * Investigator's global assessment of disease activity * HAQ-DI * Acute phase reactant value (C-reactive protein). NRI was used for missing data.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=42 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=42 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=39 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=20 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=84 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=81 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 16
|
11.9 percentage of participants
Interval 4.8 to 23.4
|
23.8 percentage of participants
Interval 13.5 to 37.0
|
23.8 percentage of participants
Interval 13.5 to 37.0
|
38.5 percentage of participants
Interval 25.4 to 52.9
|
25.0 percentage of participants
Interval 10.4 to 45.6
|
23.8 percentage of participants
Interval 16.4 to 32.7
|
30.9 percentage of participants
Interval 22.5 to 40.4
|
SECONDARY outcome
Timeframe: Week 16Population: FAS
Response defined by ACR70 criteria (improvement from baseline) at Week 16: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% improvement in at least 3 of the 5 following parameters: * Patient assessment of pain * Patient global assessment of disease activity * Investigator's global assessment of disease activity * HAQ-DI * Acute phase reactant value (C-reactive protein). NRI was used for missing data.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=42 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=42 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=39 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=20 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=84 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=81 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Week 16
|
0.0 percentage of participants
Interval 0.0 to 6.9
|
14.3 percentage of participants
Interval 6.4 to 26.3
|
7.1 percentage of participants
Interval 2.0 to 17.4
|
25.6 percentage of participants
Interval 14.6 to 39.6
|
15.0 percentage of participants
Interval 4.2 to 34.4
|
10.7 percentage of participants
Interval 5.7 to 18.0
|
16.0 percentage of participants
Interval 9.8 to 24.3
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Participants in the FAS with available data at Baseline and Week 16.
Sixty-eight joints were assessed and classified as either tender (1) or not tender (0). A negative change represents a decrease in the number of tender joints.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=40 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=41 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=38 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=18 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=81 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=79 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Tender Joint Count (TJC68): Change From Baseline to Week 16
|
-7.9 tender joints
Interval -10.6 to -5.2
|
-7.8 tender joints
Interval -10.6 to -5.1
|
-9.6 tender joints
Interval -12.4 to -6.9
|
-10.4 tender joints
Interval -13.2 to -7.5
|
-10.8 tender joints
Interval -14.9 to -6.8
|
-8.6 tender joints
Interval -10.5 to -6.6
|
-9.9 tender joints
Interval -11.8 to -8.0
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Participants in the FAS with available data at Baseline and Week 16.
Sixty-six joints were assessed and classified as either swollen (1) or not swollen (0). A negative change represents a decrease in the number of tender joints.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=40 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=41 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=38 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=18 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=81 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=79 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Swollen Joint Count (SJC): Change From Baseline to Week 16
|
-7.1 swollen joints
Interval -8.5 to -5.7
|
-6.8 swollen joints
Interval -8.3 to -5.4
|
-7.8 swollen joints
Interval -9.3 to -6.4
|
-8.3 swollen joints
Interval -9.7 to -6.8
|
-7.8 swollen joints
Interval -9.9 to -5.7
|
-7.3 swollen joints
Interval -8.5 to -6.2
|
-8.3 swollen joints
Interval -9.4 to -7.2
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Participants in the FAS with available data at Baseline and Week 16.
The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \< 0.5. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=39 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=40 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=38 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=18 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=79 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=78 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Health Assessment Questionnaire Disability Index (HAQ-DI) Score: Change From Baseline to Week 16
|
-0.089 units on a scale
Interval -0.204 to 0.026
|
-0.182 units on a scale
Interval -0.299 to -0.065
|
-0.163 units on a scale
Interval -0.28 to -0.047
|
-0.245 units on a scale
Interval -0.365 to -0.126
|
-0.147 units on a scale
Interval -0.317 to 0.023
|
-0.184 units on a scale
Interval -0.27 to -0.099
|
-0.206 units on a scale
Interval -0.291 to -0.12
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Participants in the FAS with available data at Baseline and Week 16.
The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=37 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=41 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=39 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=19 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=78 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=80 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Short Form-36 Health Status Survey (SF-36) Physical Component: Change From Baseline to Week 16
|
1.93 units on a scale
Interval 0.17 to 3.7
|
3.87 units on a scale
Interval 2.03 to 5.71
|
3.50 units on a scale
Interval 1.72 to 5.27
|
3.10 units on a scale
Interval 1.27 to 4.93
|
7.42 units on a scale
Interval 4.81 to 10.03
|
3.80 units on a scale
Interval 2.52 to 5.08
|
3.32 units on a scale
Interval 2.03 to 4.62
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Participants in the FAS with available data at Baseline and Week 16.
The SF-36 determined participant's overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=42 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=37 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=41 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=39 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=19 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=78 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=80 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
SF-36 Mental Component: Change From Baseline to Week 16
|
0.48 units on a scale
Interval -1.74 to 2.69
|
-0.36 units on a scale
Interval -2.68 to 1.96
|
2.26 units on a scale
Interval 0.03 to 4.49
|
2.84 units on a scale
Interval 0.54 to 5.14
|
-1.08 units on a scale
Interval -4.35 to 2.19
|
1.31 units on a scale
Interval -0.38 to 3.0
|
2.29 units on a scale
Interval 0.59 to 3.99
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Participants in the FAS with available data at Baseline and Week 16.
The number of fingers and toes with dactylitis (ranging from 0 to 20). A negative change represents a decrease in the number of fingers and toes affected by dactylitis.
Outcome measures
| Measure |
Placebo
n=9 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=11 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=11 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=10 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=5 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=22 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=21 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Dactylitis Count: Change From Baseline to Week 16 in Participants With Dactylitis at Baseline
|
-2.6 fingers and toes with dactylitis
Interval -3.9 to -1.4
|
-1.1 fingers and toes with dactylitis
Interval -2.2 to 0.1
|
-1.9 fingers and toes with dactylitis
Interval -3.0 to -0.8
|
-2.9 fingers and toes with dactylitis
Interval -4.1 to -1.7
|
-3.5 fingers and toes with dactylitis
Interval -5.2 to -1.8
|
-1.5 fingers and toes with dactylitis
Interval -2.4 to -0.6
|
-2.4 fingers and toes with dactylitis
Interval -3.0 to -1.9
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
Assessment of enthesitis was performed in the following 16 domains: left and right (L/R) medial epicondyle; L/R lateral epicondyle; L/R supraspinatus insertion into the greater tuberosity of humerus; L/R greater trochanter; L/R quadriceps insertion into superior border of patella; L/R patellar ligament insertion into inferior pole of patella or tibial tubercle; L/R Achilles tendon insertion into calcaneum; L/R plantar fascia insertion into calcaneum. Tenderness at each site was classified as either absent (0) or present (1) to yield total SPARCC scores ranging from 0 (0 sites with tenderness) to 16 (16 sites with tenderness). A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=27 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=27 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=24 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=25 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=11 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=51 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=49 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index: Change From Baseline to Week 16 in Participants With Enthesitis at Baseline
|
-1.1 units on a scale
Interval -2.1 to -0.2
|
-1.4 units on a scale
Interval -2.3 to -0.5
|
-2.4 units on a scale
Interval -3.3 to -1.4
|
-1.8 units on a scale
Interval -2.7 to -0.8
|
-3.7 units on a scale
Interval -5.1 to -2.3
|
-1.7 units on a scale
Interval -2.4 to -1.0
|
-2.1 units on a scale
Interval -2.7 to -1.4
|
SECONDARY outcome
Timeframe: Baseline, Week 16Population: Participants in the FAS with enthesitis at Baseline and with available data at Baseline and Week 16.
mNAPSI grades each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (\>30% of the nail); pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (\>50 pits present); nail plate crumbling on a scale of 0 (no crumbling) to 3 (\>50% of nail has crumbling); and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula. mNAPSI is calculated as the sum of all the components for all of the participants fingernails, for a minimal - maximal total score of 0 to 130. A negative change from Baseline indicates improvement.
Outcome measures
| Measure |
Placebo
n=28 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=19 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=23 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=25 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=9 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=42 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=48 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Modified Nail Psoriasis Severity Index (mNAPSI): Change From Baseline to Week 16
|
-5.2 units on a scale
Interval -7.4 to -3.0
|
-6.7 units on a scale
Interval -9.4 to -4.1
|
-5.8 units on a scale
Interval -8.2 to -3.4
|
-10.7 units on a scale
Interval -13.1 to -8.3
|
-6.8 units on a scale
Interval -10.6 to -3.0
|
-5.5 units on a scale
Interval -7.3 to -3.8
|
-8.1 units on a scale
Interval -9.9 to -6.3
|
SECONDARY outcome
Timeframe: Week 16Population: FAS
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign was assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis. PASI90 is defined as at least a 90% reduction in PASI score compared with the Baseline PASI score. The percent reduction in score is calculated as (PASI score at Baseline - score at follow-up visit) / PASI score at Baseline \* 100. The percentage of participants achieving PASI90 at Week 16 are provided. NRI was used for missing data.
Outcome measures
| Measure |
Placebo
n=21 Participants
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=12 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=18 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=23 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=9 Participants
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
Risankizumab 150 mg Every 4 Weeks; 150 mg Weeks 0, 4, 16
n=30 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks AND participants randomized to receive DB risankizumab 150 mg by SC injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0, 4, and 16; 150 mg Weeks 0 and 12
n=41 Participants
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16 AND participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
|---|---|---|---|---|---|---|---|
|
Percentage of Participants Achieving 90% Improvement in Psoriasis Area and Severity Index (PASI) Score (PASI90) at Week 16
|
9.5 percentage of participants
Interval 1.7 to 27.1
|
58.3 percentage of participants
Interval 31.5 to 81.9
|
66.7 percentage of participants
Interval 44.6 to 84.4
|
52.2 percentage of participants
Interval 33.5 to 70.4
|
55.6 percentage of participants
Interval 25.1 to 83.1
|
63.3 percentage of participants
Interval 46.7 to 77.9
|
58.5 percentage of participants
Interval 44.5 to 71.6
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 25 other events
Deaths: 0 deaths
Risankizumab 150 mg Every 4 Weeks
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Risankizumab 150 mg Weeks 0, 4, and 16
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Risankizumab 150 mg Weeks 0 and 12
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Risankizumab 75 mg Week 0
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=42 participants at risk
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=42 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=42 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=39 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=20 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Influenza
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Sepsis
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer stage IV
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Surgical and medical procedures
Nasal septal operation
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
Other adverse events
| Measure |
Placebo
n=42 participants at risk
Participants randomized to receive double-blind (DB) placebo for risankizumab by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Every 4 Weeks
n=42 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection every 4 weeks for 16 weeks.
|
Risankizumab 150 mg Weeks 0, 4, and 16
n=42 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0, 4, and 16.
|
Risankizumab 150 mg Weeks 0 and 12
n=39 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 150 mg by subcutaneous (SC) injection at Weeks 0 and 12.
|
Risankizumab 75 mg Week 0
n=20 participants at risk
Participants randomized to receive double-blind (DB) risankizumab 75 mg by subcutaneous (SC) injection at Week 0.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
General disorders
Fatigue
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Bronchitis
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Helicobacter gastritis
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Influenza
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Otitis media
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Pharyngitis
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Upper respiratory tract infection
|
11.9%
5/42 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
7.1%
3/42 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
16.7%
7/42 • Number of events 12 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
11.9%
5/42 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
23.1%
9/39 • Number of events 11 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
20.0%
4/20 • Number of events 6 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Investigations
Alanine aminotransferase increased
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.1%
2/39 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Nervous system disorders
Dizziness
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Nervous system disorders
Headache
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
7.7%
3/39 • Number of events 4 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Renal and urinary disorders
Haematuria
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
2/42 • Number of events 2 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
5.0%
1/20 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/39 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
|
Vascular disorders
Hypertension
|
7.1%
3/42 • Number of events 3 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/42 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.4%
1/42 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
2.6%
1/39 • Number of events 1 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
0.00%
0/20 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 15 weeks after the last dose of study drug (up to 31 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER