Trial Outcomes & Findings for Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis (NCT NCT01694485)
NCT ID: NCT01694485
Last Updated: 2019-06-27
Results Overview
Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline total Mayo Score (adjusted remission rate).
COMPLETED
PHASE2
359 participants
Week 8
2019-06-27
Participant Flow
Participants were enrolled at 92 centers located in North America, Europe, and Australia from 16 November 2012 to 11 May 2015. The study consisted of a 24-week double-blind treatment period, a 108-week open-label treatment period, and a safety follow-up period.
Participants were to be randomly assigned in a 2:1:2:2:2 ratio to 1 of 5 treatment groups. Due to a misalignment error, some participants were erroneously assigned to incorrect treatment resulting in a final randomization ratio different from that originally stipulated in the protocol.
Participant milestones
| Measure |
Placebo/Abrilumab 210 mg Q3M
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
|
Abrilumab 7 mg Q4W/Abrilumab 210 mg Q3M
Participants randomized to receive 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
|
Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
|
Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
|
Abrilumab 210 mg/Abrilumab 210 mg Q3M
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
117
|
22
|
40
|
100
|
80
|
|
Overall Study
Received Treatment
|
116
|
21
|
40
|
98
|
79
|
|
Overall Study
Completed Week 8 Assessment
|
106
|
18
|
38
|
94
|
76
|
|
Overall Study
Entered Open-label Period
|
100
|
19
|
36
|
88
|
68
|
|
Overall Study
COMPLETED
|
84
|
15
|
27
|
62
|
55
|
|
Overall Study
NOT COMPLETED
|
33
|
7
|
13
|
38
|
25
|
Reasons for withdrawal
| Measure |
Placebo/Abrilumab 210 mg Q3M
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks.
|
Abrilumab 7 mg Q4W/Abrilumab 210 mg Q3M
Participants randomized to receive 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
|
Abrilumab 21 mg Q4W/Abrilumab 210 mg Q3M
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
|
Abrilumab 70 mg Q4W/Abrilumab 210 mg Q3M
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
|
Abrilumab 210 mg/Abrilumab 210 mg Q3M
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24.
During the open-label period, participants received abrilumab 210 mg once every 3 months for 108 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
20
|
6
|
7
|
25
|
18
|
|
Overall Study
Sponsor Decision
|
3
|
0
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
9
|
1
|
6
|
10
|
7
|
|
Overall Study
Death
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
Placebo
n=117 Participants
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 7 mg Q4W
n=22 Participants
Participants randomized to receive 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 21 mg Q4W
n=40 Participants
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 70 mg Q4W
n=100 Participants
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 210 mg
n=80 Participants
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 13.3 • n=117 Participants
|
42.0 years
STANDARD_DEVIATION 12.4 • n=22 Participants
|
38.3 years
STANDARD_DEVIATION 11.6 • n=40 Participants
|
39.3 years
STANDARD_DEVIATION 12.2 • n=100 Participants
|
39.8 years
STANDARD_DEVIATION 12.0 • n=80 Participants
|
40.0 years
STANDARD_DEVIATION 12.5 • n=359 Participants
|
|
Age, Customized
18 - 64 years
|
113 Participants
n=117 Participants
|
22 Participants
n=22 Participants
|
40 Participants
n=40 Participants
|
99 Participants
n=100 Participants
|
80 Participants
n=80 Participants
|
354 Participants
n=359 Participants
|
|
Age, Customized
≥ 65 years
|
4 Participants
n=117 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=100 Participants
|
0 Participants
n=80 Participants
|
5 Participants
n=359 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=117 Participants
|
8 Participants
n=22 Participants
|
12 Participants
n=40 Participants
|
32 Participants
n=100 Participants
|
32 Participants
n=80 Participants
|
120 Participants
n=359 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=117 Participants
|
14 Participants
n=22 Participants
|
28 Participants
n=40 Participants
|
68 Participants
n=100 Participants
|
48 Participants
n=80 Participants
|
239 Participants
n=359 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=117 Participants
|
0 Participants
n=22 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=100 Participants
|
3 Participants
n=80 Participants
|
9 Participants
n=359 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=117 Participants
|
22 Participants
n=22 Participants
|
38 Participants
n=40 Participants
|
100 Participants
n=100 Participants
|
77 Participants
n=80 Participants
|
350 Participants
n=359 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=117 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=80 Participants
|
0 Participants
n=359 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=117 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=40 Participants
|
7 Participants
n=100 Participants
|
1 Participants
n=80 Participants
|
16 Participants
n=359 Participants
|
|
Race/Ethnicity, Customized
White
|
109 Participants
n=117 Participants
|
20 Participants
n=22 Participants
|
39 Participants
n=40 Participants
|
89 Participants
n=100 Participants
|
78 Participants
n=80 Participants
|
335 Participants
n=359 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=117 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
4 Participants
n=100 Participants
|
1 Participants
n=80 Participants
|
8 Participants
n=359 Participants
|
|
Any Prior Anti-Tumor Necrosis Factor (TNF) Use
Yes
|
69 Participants
n=117 Participants
|
6 Participants
n=22 Participants
|
10 Participants
n=40 Participants
|
56 Participants
n=100 Participants
|
39 Participants
n=80 Participants
|
180 Participants
n=359 Participants
|
|
Any Prior Anti-Tumor Necrosis Factor (TNF) Use
No
|
48 Participants
n=117 Participants
|
16 Participants
n=22 Participants
|
30 Participants
n=40 Participants
|
44 Participants
n=100 Participants
|
41 Participants
n=80 Participants
|
179 Participants
n=359 Participants
|
|
Enrollment Prior to Protocol Amendment 3
Yes
|
76 Participants
n=117 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
58 Participants
n=100 Participants
|
38 Participants
n=80 Participants
|
172 Participants
n=359 Participants
|
|
Enrollment Prior to Protocol Amendment 3
No
|
41 Participants
n=117 Participants
|
22 Participants
n=22 Participants
|
40 Participants
n=40 Participants
|
42 Participants
n=100 Participants
|
42 Participants
n=80 Participants
|
187 Participants
n=359 Participants
|
|
Duration of Ulcerative Colitis
|
7.83 years
STANDARD_DEVIATION 5.58 • n=116 Participants • Participants with available data
|
9.07 years
STANDARD_DEVIATION 6.57 • n=22 Participants • Participants with available data
|
7.05 years
STANDARD_DEVIATION 5.39 • n=40 Participants • Participants with available data
|
9.39 years
STANDARD_DEVIATION 7.25 • n=100 Participants • Participants with available data
|
9.44 years
STANDARD_DEVIATION 7.88 • n=80 Participants • Participants with available data
|
8.62 years
STANDARD_DEVIATION 6.70 • n=358 Participants • Participants with available data
|
|
Total Mayo Score
|
8.9 units on a scale
STANDARD_DEVIATION 1.5 • n=117 Participants
|
8.1 units on a scale
STANDARD_DEVIATION 1.4 • n=22 Participants
|
8.6 units on a scale
STANDARD_DEVIATION 1.7 • n=40 Participants
|
9.0 units on a scale
STANDARD_DEVIATION 1.5 • n=100 Participants
|
9.1 units on a scale
STANDARD_DEVIATION 1.4 • n=80 Participants
|
8.9 units on a scale
STANDARD_DEVIATION 1.5 • n=359 Participants
|
PRIMARY outcome
Timeframe: Week 8Population: The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted remission rates were calculated using non-responder imputation, where participants with a missing Mayo Score at week 8 were counted as non-responders.
Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment) with each item graded semi-quantitatively on a score of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, with a result ranging from 0 to 12 points. Higher scores represent more severe disease. The remission rate (percentage of participants with remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline total Mayo Score (adjusted remission rate).
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 7 mg Q4W
n=21 Participants
Participants randomized to receive 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 21 mg Q4W
n=40 Participants
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 70 mg Q4W
n=98 Participants
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 210 mg
n=79 Participants
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Remission at Week 8
Adjusted remission rate
|
4.4 percentage of participants
|
1.6 percentage of participants
|
2.9 percentage of participants
|
13.5 percentage of participants
|
13.4 percentage of participants
|
|
Percentage of Participants With Remission at Week 8
Unadjusted remission rate
|
4.3 percentage of participants
|
0.0 percentage of participants
|
2.5 percentage of participants
|
13.3 percentage of participants
|
12.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 8Population: The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted response rates were calculated using non-responder imputation, where participants with a missing Mayo Score at week 8 were counted as non-responders.
Response was defined by a decrease from baseline in the total Mayo Score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore ≥ 1 point or an absolute rectal bleeding subscore = 0 or 1. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The total Mayo Score is the sum of the four item scores, ranging from 0 to 12 points. Higher scores represent more severe disease. The response rate (percentage of participants with response) was calculated based on observed data (unadjusted response rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline total Mayo Score (adjusted response rate).
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 7 mg Q4W
n=21 Participants
Participants randomized to receive 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 21 mg Q4W
n=40 Participants
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 70 mg Q4W
n=98 Participants
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 210 mg
n=79 Participants
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Response at Week 8
Unadjusted response rate
|
25.9 percentage of participants
|
14.3 percentage of participants
|
50.0 percentage of participants
|
49.0 percentage of participants
|
46.8 percentage of participants
|
|
Percentage of Participants With Response at Week 8
Adjusted response rate
|
26.0 percentage of participants
|
12.3 percentage of participants
|
47.2 percentage of participants
|
49.4 percentage of participants
|
47.4 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8Population: The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted healing rates were calculated using non-responder imputation, where participants with missing rectosigmoidoscopy scores at week 8 were counted as non-responders.
Mucosal healing was defined using the rectosigmoidoscopy subscore of Mayo assessment as absolute subscore for rectosigmoidoscopy of 0 or 1. Flexible rectosigmoidoscopy was performed as part of the Mayo assessment, graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher score represents more severe disease status. The healing rate (percentage of participants with mucosal healing) was calculated based on observed data (unadjusted healing rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline rectosigmoidoscopy score (adjusted healing rate).
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 7 mg Q4W
n=21 Participants
Participants randomized to receive 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 21 mg Q4W
n=40 Participants
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 70 mg Q4W
n=98 Participants
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 210 mg
n=79 Participants
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Mucosal Healing at Week 8
Unadjusted healing rate
|
21.6 percentage of participants
|
14.3 percentage of participants
|
15.0 percentage of participants
|
32.7 percentage of participants
|
29.1 percentage of participants
|
|
Percentage of Participants With Mucosal Healing at Week 8
Adjusted healing rate
|
16.8 percentage of participants
|
12.2 percentage of participants
|
13.9 percentage of participants
|
32.2 percentage of participants
|
29.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 8 and week 24Population: The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both non-adjusted and adjusted remission rates were calculated using non-responder imputation, where participants with missing Mayo Score at week 8 or week 16 were counted as non-responders.
Remission was defined as a total Mayo Score ≤ 2 points, with no individual subscore \> 1 point. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24. The Mayo Score is a composite index of four items (stool frequency, rectal bleeding, rectosigmoidoscopy findings, and physician's global assessment), each graded semi-quantitatively on a scale of 0 to 3 where 0 represents normal and higher scores represent more severe disease status. The total Mayo Score is the sum of the four item scores, with a and ranges from 0 to 12 points. Higher scores represent more severe disease. The remission rate (percentage of participants with sustained remission) was calculated based on observed data (unadjusted remission rate) and also after applying a logistic regression model including the factors of treatment group, stratification factors (prior anti-TNF use and pre- versus post-Protocol Amendment 3) and baseline total Mayo Score (adjusted remission rate).
Outcome measures
| Measure |
Placebo
n=116 Participants
Participants randomized to receive placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 7 mg Q4W
n=21 Participants
Participants randomized to receive 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 21 mg Q4W
n=40 Participants
Participants randomized to receive 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 70 mg Q4W
n=98 Participants
Participants randomized to receive 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
Abrilumab 210 mg
n=79 Participants
Participants randomized to receive a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Sustained Remission at Week 8 and Week 24
Unadjusted remission rate
|
2.6 percentage of participants
|
0.0 percentage of participants
|
2.5 percentage of participants
|
8.2 percentage of participants
|
3.8 percentage of participants
|
|
Percentage of Participants With Sustained Remission at Week 8 and Week 24
Adjusted remission rate
|
3.3 percentage of participants
|
1.6 percentage of participants
|
2.8 percentage of participants
|
9.1 percentage of participants
|
4.3 percentage of participants
|
Adverse Events
DB Period: Placebo
DB Period: Abrilumab 7 mg Q4W
DB Period: Abrilumab 21 mg Q4W
DB Period: Abrilumab 70 mg Q4W
DB Period: Abrilumab 210 mg
OL Period: Placebo/Abrilumab 210 mg Q3M
OL Period: Abrilumab 7 mg Q4W/210 mg Q3M
OL Period: Abrilumab 21 mg Q4W/210 mg Q3M
OL Period: Abrilumab 70 mg Q4W/210 mg Q3M
OL Period: Abrilumab 210 mg/210 mg Q3M
Serious adverse events
| Measure |
DB Period: Placebo
n=116 participants at risk
Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind (DB) treatment period.
|
DB Period: Abrilumab 7 mg Q4W
n=20 participants at risk
Participants received 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
|
DB Period: Abrilumab 21 mg Q4W
n=40 participants at risk
Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
DB Period: Abrilumab 70 mg Q4W
n=99 participants at risk
Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
DB Period: Abrilumab 210 mg
n=79 participants at risk
Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
OL Period: Placebo/Abrilumab 210 mg Q3M
n=100 participants at risk
Participants who received placebo during the double-blind treatment period received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks during the open-label (OL) treatment period.
|
OL Period: Abrilumab 7 mg Q4W/210 mg Q3M
n=18 participants at risk
Participants who received 7 mg abrilumab Q4W in the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
|
OL Period: Abrilumab 21 mg Q4W/210 mg Q3M
n=36 participants at risk
During the open-label period, participants who received 21 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks.
|
OL Period: Abrilumab 70 mg Q4W/210 mg Q3M
n=89 participants at risk
Participants who received 70 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
|
OL Period: Abrilumab 210 mg/210 mg Q3M
n=68 participants at risk
Participants who received 210 mg abrilumab during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Heart valve incompetence
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.7%
2/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
4.3%
5/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.0%
6/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
2/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal dysplasia
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ileus
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Megacolon
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Drug hypersensitivity
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Sarcoidosis
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Anal infection
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Skin infection
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Post lumbar puncture syndrome
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Norovirus test positive
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr virus associated lymphoma
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Migraine
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
DB Period: Placebo
n=116 participants at risk
Participants received placebo by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind (DB) treatment period.
|
DB Period: Abrilumab 7 mg Q4W
n=20 participants at risk
Participants received 7 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks (Q4W) thereafter until week 24 during the double-blind treatment period.
|
DB Period: Abrilumab 21 mg Q4W
n=40 participants at risk
Participants received 21 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
DB Period: Abrilumab 70 mg Q4W
n=99 participants at risk
Participants received 70 mg abrilumab by subcutaneous injection on day 1, week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
DB Period: Abrilumab 210 mg
n=79 participants at risk
Participants received a single dose of 210 mg abrilumab by subcutaneous injection on day 1, followed by placebo at week 2, week 4, and every 4 weeks thereafter until week 24 during the double-blind treatment period.
|
OL Period: Placebo/Abrilumab 210 mg Q3M
n=100 participants at risk
Participants who received placebo during the double-blind treatment period received abrilumab 210 mg once every 3 months (Q3M) for 108 weeks during the open-label (OL) treatment period.
|
OL Period: Abrilumab 7 mg Q4W/210 mg Q3M
n=18 participants at risk
Participants who received 7 mg abrilumab Q4W in the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
|
OL Period: Abrilumab 21 mg Q4W/210 mg Q3M
n=36 participants at risk
During the open-label period, participants who received 21 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks.
|
OL Period: Abrilumab 70 mg Q4W/210 mg Q3M
n=89 participants at risk
Participants who received 70 mg abrilumab Q4W during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
|
OL Period: Abrilumab 210 mg/210 mg Q3M
n=68 participants at risk
Participants who received 210 mg abrilumab during the DB treatment period received abrilumab 210 mg once every 3 months for 108 weeks during the open-label period.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
General disorders
Localised oedema
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
2/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
2/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
3/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
6/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.9%
2/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Eye swelling
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.6%
3/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.5%
3/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
8/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
3/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.7%
6/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
3.4%
4/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
2/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
7/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.6%
6/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.0%
17/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
22.2%
4/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
30.6%
11/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
24.7%
22/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.8%
8/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.5%
3/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
5/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
2/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
2/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Haematochezia
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
3.4%
4/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
2/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.3%
5/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
2/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
2.6%
3/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
2.6%
3/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.1%
8/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
3/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Hyperthermia
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Influenza like illness
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Food allergy
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Candida infection
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
2/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Conjunctivitis
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
1.7%
2/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
3/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
3.4%
4/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
2/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.2%
2/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
7/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.0%
6/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.1%
9/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
8/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.0%
9/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.8%
6/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.7%
2/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
5/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
2/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight decreased
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.4%
3/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
5/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.0%
4/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
11/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.6%
6/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.0%
11/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
2/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
3/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
9/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
4/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
5/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.0%
8/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rheumatic disorder
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
6.0%
7/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
2/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
11/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.1%
8/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.0%
3/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.1%
2/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
5/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
4/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.7%
2/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
5/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.5%
4/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
1/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.5%
2/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
2/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
3/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
4/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
5/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
1/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.0%
1/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.8%
1/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.1%
1/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.86%
1/116 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/20 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/40 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
5/99 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/79 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
1/100 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/18 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/36 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/89 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
1/68 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant who was randomized to the 7 mg abrilumab arm was treated with 70 mg abrilumab and is counted in the Abrilumab 70 mg group for safety assessments in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER