Trial Outcomes & Findings for Abrilumab (AMG 181) in Adults With Moderate to Severe Crohn's Disease (NCT NCT01696396)
NCT ID: NCT01696396
Last Updated: 2019-06-27
Results Overview
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150 at week 8. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. 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 CDAI Score (adjusted remission rate).
COMPLETED
PHASE2
254 participants
Week 8
2019-06-27
Participant Flow
This study was conducted at 84 centers in Canada, European Union, and the United States. Participants were enrolled from 04 December 2012 to 30 September 2014. 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 2:1:2:1 ratio to 1 of 4 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 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 (Q4W) 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
|
100
|
27
|
85
|
42
|
|
Overall Study
Received Study Drug
|
98
|
26
|
84
|
41
|
|
Overall Study
Entered Open-label Period
|
84
|
21
|
75
|
37
|
|
Overall Study
COMPLETED
|
69
|
20
|
59
|
28
|
|
Overall Study
NOT COMPLETED
|
31
|
7
|
26
|
14
|
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 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 (Q4W) 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
|
19
|
5
|
19
|
11
|
|
Overall Study
Decision by Sponsor
|
3
|
1
|
2
|
2
|
|
Overall Study
Lost to Follow-up
|
9
|
1
|
4
|
1
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Participants with available data
Baseline characteristics by cohort
| Measure |
Placebo
n=100 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 21 mg Q4W
n=27 Participants
Participants randomized to receive 21 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.
|
Abrilumab 70 mg Q4W
n=85 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=42 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=254 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.2 years
STANDARD_DEVIATION 11.2 • n=100 Participants
|
38.9 years
STANDARD_DEVIATION 14.2 • n=27 Participants
|
35.6 years
STANDARD_DEVIATION 11.8 • n=85 Participants
|
36.5 years
STANDARD_DEVIATION 9.4 • n=42 Participants
|
36.4 years
STANDARD_DEVIATION 11.4 • n=254 Participants
|
|
Age, Customized
18 - 64 years
|
99 Participants
n=100 Participants
|
27 Participants
n=27 Participants
|
85 Participants
n=85 Participants
|
42 Participants
n=42 Participants
|
253 Participants
n=254 Participants
|
|
Age, Customized
≥ 65 years
|
1 Participants
n=100 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=254 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=100 Participants
|
12 Participants
n=27 Participants
|
51 Participants
n=85 Participants
|
23 Participants
n=42 Participants
|
144 Participants
n=254 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=100 Participants
|
15 Participants
n=27 Participants
|
34 Participants
n=85 Participants
|
19 Participants
n=42 Participants
|
110 Participants
n=254 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=100 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=254 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
100 Participants
n=100 Participants
|
26 Participants
n=27 Participants
|
85 Participants
n=85 Participants
|
41 Participants
n=42 Participants
|
252 Participants
n=254 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=100 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=85 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=254 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=100 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=254 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=100 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=85 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=254 Participants
|
|
Race/Ethnicity, Customized
White
|
97 Participants
n=100 Participants
|
26 Participants
n=27 Participants
|
82 Participants
n=85 Participants
|
40 Participants
n=42 Participants
|
245 Participants
n=254 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=100 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=85 Participants
|
0 Participants
n=42 Participants
|
5 Participants
n=254 Participants
|
|
Any Prior Anti-Tumor Necrosis Factor (TNF) Use
Yes
|
80 Participants
n=100 Participants
|
21 Participants
n=27 Participants
|
67 Participants
n=85 Participants
|
33 Participants
n=42 Participants
|
201 Participants
n=254 Participants
|
|
Any Prior Anti-Tumor Necrosis Factor (TNF) Use
No
|
20 Participants
n=100 Participants
|
6 Participants
n=27 Participants
|
18 Participants
n=85 Participants
|
9 Participants
n=42 Participants
|
53 Participants
n=254 Participants
|
|
Enrollment Prior to Protocol Amendment 3
Yes
|
44 Participants
n=100 Participants
|
0 Participants
n=27 Participants
|
29 Participants
n=85 Participants
|
16 Participants
n=42 Participants
|
89 Participants
n=254 Participants
|
|
Enrollment Prior to Protocol Amendment 3
No
|
56 Participants
n=100 Participants
|
27 Participants
n=27 Participants
|
56 Participants
n=85 Participants
|
26 Participants
n=42 Participants
|
165 Participants
n=254 Participants
|
|
Duration of Crohn's Diease
|
11.07 years
STANDARD_DEVIATION 8.33 • n=100 Participants
|
12.58 years
STANDARD_DEVIATION 9.55 • n=27 Participants
|
10.69 years
STANDARD_DEVIATION 7.75 • n=85 Participants
|
11.31 years
STANDARD_DEVIATION 7.54 • n=42 Participants
|
11.15 years
STANDARD_DEVIATION 8.12 • n=254 Participants
|
|
Crohn's Disease Activity Index (CDAI) Score
|
303.8 units on a scale
STANDARD_DEVIATION 63.2 • n=99 Participants • Participants with available data
|
310.0 units on a scale
STANDARD_DEVIATION 83.5 • n=27 Participants • Participants with available data
|
314.0 units on a scale
STANDARD_DEVIATION 60.4 • n=84 Participants • Participants with available data
|
319.3 units on a scale
STANDARD_DEVIATION 67.5 • n=42 Participants • Participants with available data
|
310.5 units on a scale
STANDARD_DEVIATION 65.3 • n=252 Participants • Participants with available data
|
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 CDAI Score at week 8 were counted as non-responders.
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150 at week 8. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. 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 CDAI Score (adjusted remission rate).
Outcome measures
| Measure |
Placebo
n=98 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 21 mg Q4W
n=26 Participants
Participants randomized to receive 21 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.
|
Abrilumab 70 mg Q4W
n=84 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=41 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
Unadjusted remission rate
|
13.3 percentage of participants
|
23.1 percentage of participants
|
14.3 percentage of participants
|
19.5 percentage of participants
|
|
Percentage of Participants With Remission at Week 8
Adjusted remission rate
|
12.8 percentage of participants
|
23.1 percentage of participants
|
14.4 percentage of participants
|
21.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: 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 CDAI Score at week 12 were counted as non-responders.
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. 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 CDAI Score (adjusted remission rate).
Outcome measures
| Measure |
Placebo
n=98 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 21 mg Q4W
n=26 Participants
Participants randomized to receive 21 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.
|
Abrilumab 70 mg Q4W
n=84 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=41 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 12
Unadjusted remission rate
|
18.1 percentage of participants
|
33.3 percentage of participants
|
25.3 percentage of participants
|
27.0 percentage of participants
|
|
Percentage of Participants With Remission at Week 12
Adjusted remission rate
|
20.1 percentage of participants
|
43.8 percentage of participants
|
31.0 percentage of participants
|
34.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: 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 CDAI Score at week 12 were counted as non-responders.
Response was defined as either remission (a CDAI score \< 150) or a decrease from baseline in the CDAI score of ≥ 100 points. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. 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 CDAI score (adjusted response rate).
Outcome measures
| Measure |
Placebo
n=98 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 21 mg Q4W
n=26 Participants
Participants randomized to receive 21 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.
|
Abrilumab 70 mg Q4W
n=84 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=41 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 12
Unadjusted response rate
|
27.7 percentage of participants
|
41.7 percentage of participants
|
45.3 percentage of participants
|
43.2 percentage of participants
|
|
Percentage of Participants With Response at Week 12
Adjusted response rate
|
35.3 percentage of participants
|
50.4 percentage of participants
|
55.1 percentage of participants
|
50.9 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 CDAI Score at week 8 were counted as non-responders.
Response was defined as either remission (a CDAI score \< 150) or a decrease from baseline in the CDAI score of ≥ 100 points. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. 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 CDAI score (adjusted response rate).
Outcome measures
| Measure |
Placebo
n=98 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 21 mg Q4W
n=26 Participants
Participants randomized to receive 21 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.
|
Abrilumab 70 mg Q4W
n=84 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=41 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
|
26.4 percentage of participants
|
33.3 percentage of participants
|
42.9 percentage of participants
|
30.6 percentage of participants
|
|
Percentage of Participants With Response at Week 8
Adjusted response rate
|
30.6 percentage of participants
|
33.8 percentage of participants
|
46.6 percentage of participants
|
32.6 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12 and week 24Population: The full analysis set includes all randomized participants who received at least 1 dose of study drug. Both unadjusted and adjusted sustained remission rates were calculated using non-responder imputation, where participants with missing CDAI scores at week 12 or week 24 were counted as non-responders.
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150. Sustained remission was defined as achieving the criteria for remission at both week 12 and week 24. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. 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 CDAI Score (adjusted remission rate).
Outcome measures
| Measure |
Placebo
n=98 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 21 mg Q4W
n=26 Participants
Participants randomized to receive 21 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.
|
Abrilumab 70 mg Q4W
n=84 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=41 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 Both Week 12 and Week 24
Unadjusted remission rate
|
8.2 percentage of participants
|
19.2 percentage of participants
|
11.9 percentage of participants
|
17.1 percentage of participants
|
|
Percentage of Participants With Sustained Remission at Both Week 12 and Week 24
Adjusted remission rate
|
9.0 percentage of participants
|
25.0 percentage of participants
|
14.0 percentage of participants
|
21.7 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 unadjusted and adjusted sustained remission rates were calculated using non-responder imputation, where participants with missing CDAI scores at week 8 or week 24 were counted as non-responders.
Remission was defined as a Crohn's Disease Activity Index (CDAI) score \< 150. Sustained remission was defined as achieving the criteria for remission at both week 8 and week 24. The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity. 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 CDAI Score (adjusted remission rate).
Outcome measures
| Measure |
Placebo
n=98 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 21 mg Q4W
n=26 Participants
Participants randomized to receive 21 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.
|
Abrilumab 70 mg Q4W
n=84 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=41 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 Both Week 8 and Week 24
Unadjusted remission rate
|
7.1 percentage of participants
|
15.4 percentage of participants
|
9.5 percentage of participants
|
12.2 percentage of participants
|
|
Percentage of Participants With Sustained Remission at Both Week 8 and Week 24
Adjusted remission rate
|
5.9 percentage of participants
|
14.3 percentage of participants
|
8.7 percentage of participants
|
12.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 12Population: The full analysis set includes all randomized participants who received at least 1 dose of study drug. Missing data were handled using the inverse probability weighting (IPW) method.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
Outcome measures
| Measure |
Placebo
n=98 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 21 mg Q4W
n=26 Participants
Participants randomized to receive 21 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.
|
Abrilumab 70 mg Q4W
n=84 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=41 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.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI Score at Week 12
|
-55.32 units on a scale
Standard Error 11.41
|
-92.16 units on a scale
Standard Error 21.85
|
-97.41 units on a scale
Standard Error 12.92
|
-96.11 units on a scale
Standard Error 22.78
|
SECONDARY outcome
Timeframe: Baseline and week 8Population: The full analysis set includes all randomized participants who received at least 1 dose of study drug. Missing data were handled using the inverse probability weighting (IPW) method.
The CDAI is a weighted, composite index of 8 disease variables (stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations or fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight). Scores range from approximately 0 to 600, with a higher score indicating more-severe disease activity.
Outcome measures
| Measure |
Placebo
n=98 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 21 mg Q4W
n=26 Participants
Participants randomized to receive 21 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.
|
Abrilumab 70 mg Q4W
n=84 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=41 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.
|
|---|---|---|---|---|
|
Change From Baseline in CDAI Score at Week 8
|
-64.05 units on a scale
Standard Error 9.62
|
-80.42 units on a scale
Standard Error 20.86
|
-91.52 units on a scale
Standard Error 11.78
|
-87.64 units on a scale
Standard Error 19.89
|
Adverse Events
DB Period: Placebo
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 21 mg Q4W/210 mg Q3M
OL Period: Abrilumab 70 mg Q4W/210 mg Q3M
Period: Abrilumab 210 mg/210 mg Q3M
Serious adverse events
| Measure |
DB Period: Placebo
n=98 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 21 mg Q4W
n=25 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=85 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=41 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=84 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 21 mg Q4W/210 mg Q3M
n=20 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=76 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.
|
Period: Abrilumab 210 mg/210 mg Q3M
n=37 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
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Crohn's disease
|
9.2%
9/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.0%
4/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.5%
3/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.7%
9/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.5%
8/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.2%
6/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Enterocolonic fistula
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.5%
3/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chills
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 wall abscess
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
3/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Escherichia sepsis
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
External ear cellulitis
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 viral
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Intrauterine infection
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 parainfluenzae viral
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tubo-ovarian abscess
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Vulval abscess
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Anastomotic leak
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Clavicle fracture
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Intestinal anastomosis complication
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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)
Chronic myeloid leukaemia
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Nephritis
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Pleuritic pain
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Social circumstances
Aborted pregnancy
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Ileocolectomy
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Scoliosis surgery
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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=98 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 21 mg Q4W
n=25 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=85 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=41 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=84 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 21 mg Q4W/210 mg Q3M
n=20 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=76 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.
|
Period: Abrilumab 210 mg/210 mg Q3M
n=37 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
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
3/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
3/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Tinnitus
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
3/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
9.2%
9/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.4%
8/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.7%
9/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.2%
10/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
3/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Crohn's disease
|
8.2%
8/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.7%
14/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.8%
12/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.1%
3/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
4/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.0%
5/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.6%
5/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
8.2%
8/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
3/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
7/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.6%
5/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.8%
4/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Proctalgia
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Toothache
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
3/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.5%
3/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
3/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.0%
5/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.0%
5/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
4.1%
4/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
3/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
3/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
4.1%
4/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
3/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
4/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.0%
5/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.2%
7/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.1%
3/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
3/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
4/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
4/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.0%
3/20 • 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.5%
5/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.3%
4/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.5%
3/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
4/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
6.1%
6/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.5%
3/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.2%
7/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 viral
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
3/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
4/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.2%
10/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.2%
6/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
11.2%
11/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
7/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
3/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
12/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
18.4%
14/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.2%
6/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
3/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
7/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
6/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.1%
3/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
6/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
3/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
3/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Fall
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood iron decreased
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood urea increased
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Clostridium test positive
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Decreased appetite
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Magnesium deficiency
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Vitamin B12 deficiency
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Vitamin D deficiency
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Zinc deficiency
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
10.2%
10/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.4%
8/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
3/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.0%
5/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.2%
7/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.5%
5/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
4.1%
4/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.9%
3/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Muscle spasms
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Myalgia
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.3%
3/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
7.1%
7/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
4/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
11.2%
11/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.0%
4/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.1%
12/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
19.5%
8/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.3%
7/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.0%
3/20 • 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.1%
3/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Memory impairment
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
7/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
4/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.1%
3/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Insomnia
|
3.1%
3/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
3/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.6%
5/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Restlessness
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Dysuria
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Urinary incontinence
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Hiccups
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Oropharyngeal pain
|
3.1%
3/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.7%
4/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.9%
2/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.8%
4/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.1%
3/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Pneumothorax
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.0%
2/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
Hyperhidrosis
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
2/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.0%
1/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
6/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.6%
2/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.8%
4/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 maculo-papular
|
1.0%
1/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.7%
1/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Surgical and medical procedures
Female sterilisation
|
0.00%
0/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
2.0%
2/98 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/25 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/85 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.4%
1/41 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.2%
1/84 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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 randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
1/76 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses in both treatment periods. Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
2/37 • From first dose of study drug to week 24 in the double-blind period and from first dose of study drug in the open-label period to 12 weeks after last dose in the open-label period (up to 108 weeks).
One participant randomized to the 21 mg abrilumab treatment group received 70 mg abrilumab in error and is counted in the Abrilumab 70 mg group for safety analyses 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