Trial Outcomes & Findings for Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis (NCT NCT01860976)
NCT ID: NCT01860976
Last Updated: 2022-04-05
Results Overview
The American College of Rheumatology (ACR) 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
489 participants
Primary outcome timeframe
Day 169
Results posted on
2022-04-05
Participant Flow
424 were Randomized and Treated
Participant milestones
| Measure |
Abatacept
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Blinded Treatment
STARTED
|
213
|
211
|
|
Blinded Treatment
COMPLETED
|
125
|
98
|
|
Blinded Treatment
NOT COMPLETED
|
88
|
113
|
|
Open-Label
STARTED
|
197
|
185
|
|
Open-Label
COMPLETED
|
169
|
166
|
|
Open-Label
NOT COMPLETED
|
28
|
19
|
|
Long Term Extension
STARTED
|
106
|
0
|
|
Long Term Extension
COMPLETED
|
81
|
0
|
|
Long Term Extension
NOT COMPLETED
|
25
|
0
|
Reasons for withdrawal
| Measure |
Abatacept
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Blinded Treatment
Adverse Event
|
1
|
3
|
|
Blinded Treatment
Lack of Efficacy
|
5
|
12
|
|
Blinded Treatment
Subject request to discontinue treatment
|
2
|
3
|
|
Blinded Treatment
Withdrawal by Subject
|
3
|
5
|
|
Blinded Treatment
Subject no longer met criteria
|
1
|
0
|
|
Blinded Treatment
Entered Open-Label in error
|
0
|
1
|
|
Blinded Treatment
Early Escape: Transitioned to OL period
|
76
|
89
|
|
Open-Label
Adverse Event
|
2
|
4
|
|
Open-Label
Lack of Efficacy
|
16
|
8
|
|
Open-Label
Lost to Follow-up
|
1
|
2
|
|
Open-Label
Subject request discontinue treatment
|
4
|
3
|
|
Open-Label
Withdrawal by Subject
|
4
|
1
|
|
Open-Label
Other Reasons
|
1
|
1
|
|
Long Term Extension
Adverse Event
|
4
|
0
|
|
Long Term Extension
Lack of Efficacy
|
2
|
0
|
|
Long Term Extension
Subject request to discontinue treatment
|
10
|
0
|
|
Long Term Extension
Lost to Follow-up
|
2
|
0
|
|
Long Term Extension
subject withdrew consent
|
7
|
0
|
Baseline Characteristics
Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
Total
n=424 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 10.67 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 11.26 • n=7 Participants
|
50.4 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
121 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
195 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
393 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 169Population: All treated participants
The American College of Rheumatology (ACR) 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Outcome measures
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of ACR 20 Responders at Day 169
|
39.4 Percentage of participants
Interval 32.9 to 46.0
|
22.3 Percentage of participants
Interval 16.7 to 27.9
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: All treated participants
Participants were considered responders if their HAQ score decreased at least 0.35 from baseline. The number of HAQ responders was divided by the number of treated participants and expressed as a percentage. Scoring conventions are based on the Standard Disability Index of HAQ/HAQ-DI using the 20 response items. For each of the 8 disability categories there is an "aids/devices" companion variable that is used to record the type of assistance, if any, a participant uses for his/her usual activities. If either "aids/devices" and/or "assistance from another person" are checked for a disability category, the score for this category is set to "2" (much difficulty), if the original score was "0" (no difficulty) or "1" (some difficulty). The HAQ-DI is then calculated by summing the adjusted categories scores and dividing by the number of categories answered. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Outcome measures
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of Health Assessment Questionnaire (HAQ) Responders at Day 169
|
31.0 percentage of participants
Interval 24.8 to 37.2
|
23.7 percentage of participants
Interval 18.0 to 29.4
|
SECONDARY outcome
Timeframe: Day 169Population: All treated TNFi-naïve participants
The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-naive participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Outcome measures
| Measure |
Abatacept
n=84 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=81 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of ACR 20 Responders at Day 169 in the TNFi-naïve Subpopulation
|
44.0 Percentage of participants
Interval 33.4 to 54.7
|
22.2 Percentage of participants
Interval 13.2 to 31.3
|
SECONDARY outcome
Timeframe: Day 169Population: All treated TNFi-exposed participants
The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts and a 20% in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 20 responders was divided by the number of treated, TNFi-exposed participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Outcome measures
| Measure |
Abatacept
n=129 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=130 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of ACR 20 Responders at Day 169 in the TNFi-exposed Subpopulation
|
36.4 Percentage of participants
Interval 28.1 to 44.7
|
22.3 Percentage of participants
Interval 15.2 to 29.5
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: All treated participants
The number of radiographic non-progressors in total PsA-Modified Sharp van der Heijde score (SHS) at Day 169 was divided by the number of treated participants and expressed as a percentage. Non-progression was defined as a change from baseline in total PsA modified SHS ≤0. Early escape participants, and participants with missing data at day 169 were imputed as non-progressors.
Outcome measures
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of Non-progressors in Total PsA-modified SHS at Day 169
|
42.7 Percentage of participants
Interval 36.1 to 49.4
|
32.7 Percentage of participants
Interval 26.4 to 39.0
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: All treated participants with \>= 3% BSA of psoriatic skin involvement at randomization
The number of participants who achieved at least 50% improvement from baseline in Psoriasis Area and Severity Index Arthritis (PASI 50) at Day 169 was divided by the number of treated participants with BSA \>= 3% and expressed as a percentage. Only participants with \>= 3% body surface area (BSA) of psoriatic skin involvement at randomization were included in this analysis.
Outcome measures
| Measure |
Abatacept
n=146 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=148 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of Participants Achieving a PASI 50 at Day 169 in Participants With Baseline BSA >= 3%
|
26.7 Percentage of participants
Interval 19.5 to 33.9
|
19.6 Percentage of participants
Interval 13.2 to 26.0
|
SECONDARY outcome
Timeframe: Day 169Population: All treated participants
The ACR 50 and ACR 70 definition of improvement is a 50% or 70% improvement, respectively, over baseline in tender and swollen joint counts and a 50% or 70% improvement in 3 of the 5 remaining core data set measures (participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, acute phase reactant value). The number of ACR 50 and ACR 70 responders was divided by the number of treated participants and expressed as a percentage. Early escape participants, and participants with missing data at day 169 were imputed as non-responders.
Outcome measures
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportions of ACR 50 and ACR 70 Responders at Day 169
ACR 50
|
19.2 Percentage of participants
Interval 14.0 to 24.5
|
12.3 Percentage of participants
Interval 7.9 to 16.8
|
|
Proportions of ACR 50 and ACR 70 Responders at Day 169
ACR 70
|
10.3 Percentage of participants
Interval 6.2 to 14.4
|
6.6 Percentage of participants
Interval 3.3 to 10.0
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: All treated participants
Adjusted mean change in scores on the Short Form 36 physical and mental function assessment (SF-36) from baseline were analyzed from the physical component summary (PCS) mental component summary (MCS). The SF-36 is a participant questionnaire assessing 8 domains of health status: physical functioning, pain, vitality, social functioning, psychological functioning, general health perception, and role limitations due to physical and emotional problems. The instrument can be divided into two summary scores, physical and mental component score. The scores range from 0 to 100, with a higher score indicating better quality of life. The two summary scores (PCS and MCS) will be calculated by taking a weighted linear combination of the 8 individual subscales.
Outcome measures
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Mean Change From Baseline in SF-36 Physical and Mental Components at Day 169
PCS
|
5.11 SF-36 points
Standard Error 0.637
|
3.69 SF-36 points
Standard Error 0.707
|
|
Mean Change From Baseline in SF-36 Physical and Mental Components at Day 169
MCS
|
2.56 SF-36 points
Standard Error 0.826
|
2.62 SF-36 points
Standard Error 0.924
|
SECONDARY outcome
Timeframe: Baseline to Day 169Population: All treated participants
Blood samples were collected at Days 1, 85 and 169 and assayed for the presence of abatacept-specific antibodies. The number of participants with at least one positive immunogenicity response was divided by the number of treated participants and expressed as a percentage.
Outcome measures
| Measure |
Abatacept
n=203 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=198 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of Participants With at Least One Positive Immunogenicity Response up to Day 169 Relative to Baseline
|
3.9 Percentage of participants
|
8.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 169Population: All Treated Participants
Proportion of participants with AEs at Day 169
Outcome measures
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of Participants With AEs at Day 169
|
54.5 Percentage of participants
|
53.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 169Population: All Treated Participants
Proportion of participants with SAEs at Day 169
Outcome measures
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of Participants With SAEs at Day 169
|
2.8 Percentage of participants
|
4.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 169Population: All Treated Participants
Proportion of participants with AEs leading to discontinuation at Day 169
Outcome measures
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of Participants With AEs Leading to Discontinuation at Day 169
|
1.4 Percentage of participants
|
1.9 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 169Population: All Treated Participants
Proportion of participant deaths at Day 169
Outcome measures
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of Participant Deaths at Day 169
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 169Population: All Treated Participants
Proportion of participants with marked laboratory abnormalities at Day 169
Outcome measures
| Measure |
Abatacept
n=213 Participants
Abatacept 125mg, self-administered subcutaneously, once weekly
|
Placebo
n=211 Participants
Placebo, self-administered subcutaneously, once weekly.
|
|---|---|---|
|
Proportion of Participants With Marked Laboratory Abnormalities at Day 169
|
3.2 Percentage of participants
|
5.4 Percentage of participants
|
Adverse Events
ABATACEPT DURING DOUBLE-BLIND PERIOD
Serious events: 6 serious events
Other events: 39 other events
Deaths: 0 deaths
PLACEBO DURING DOUBLE-BLIND PERIOD
Serious events: 9 serious events
Other events: 43 other events
Deaths: 0 deaths
ABATACEPT DURING OPEN-LABEL PERIOD
Serious events: 29 serious events
Other events: 92 other events
Deaths: 0 deaths
ABATACEPT DURING OPEN-LABEL EXTENSION PERIOD
Serious events: 20 serious events
Other events: 103 other events
Deaths: 0 deaths
ABATACEPT DURING LONG-TERM EXTENSION PERIOD
Serious events: 17 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABATACEPT DURING DOUBLE-BLIND PERIOD
n=213 participants at risk
|
PLACEBO DURING DOUBLE-BLIND PERIOD
n=211 participants at risk
|
ABATACEPT DURING OPEN-LABEL PERIOD
n=382 participants at risk
|
ABATACEPT DURING OPEN-LABEL EXTENSION PERIOD
n=322 participants at risk
|
ABATACEPT DURING LONG-TERM EXTENSION PERIOD
n=106 participants at risk
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
1.2%
4/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
1.9%
2/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.62%
2/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.52%
2/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.93%
3/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
2.8%
3/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Ear and labyrinth disorders
Meniere's disease
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Gastrointestinal disorders
Gastric mucosa erythema
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
General disorders
Chest pain
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
General disorders
Incarcerated hernia
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Hepatobiliary disorders
Hepatic fibrosis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Abscess limb
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Appendicitis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Cellulitis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Gastroenteritis
|
0.94%
2/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Groin abscess
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
0.47%
1/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Pneumonia
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Musculoskeletal and connective tissue disorders
Chondropathy
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.47%
1/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Musculoskeletal and connective tissue disorders
Metatarsalgia
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal adenocarcinoma
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Nervous system disorders
Demyelination
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.94%
1/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Reproductive system and breast disorders
Polycystic ovaries
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Respiratory, thoracic and mediastinal disorders
Acute chest syndrome
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.47%
1/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.47%
1/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Skin and subcutaneous tissue disorders
Erythrodermic psoriasis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.47%
1/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Vascular disorders
Venous thrombosis
|
0.47%
1/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
Other adverse events
| Measure |
ABATACEPT DURING DOUBLE-BLIND PERIOD
n=213 participants at risk
|
PLACEBO DURING DOUBLE-BLIND PERIOD
n=211 participants at risk
|
ABATACEPT DURING OPEN-LABEL PERIOD
n=382 participants at risk
|
ABATACEPT DURING OPEN-LABEL EXTENSION PERIOD
n=322 participants at risk
|
ABATACEPT DURING LONG-TERM EXTENSION PERIOD
n=106 participants at risk
|
|---|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
3.3%
7/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
2.4%
5/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
5.0%
19/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
5.3%
17/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
14.2%
15/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Influenza
|
1.9%
4/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
1.4%
3/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
2.4%
9/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
5.3%
17/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
3.8%
4/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
9/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
5.2%
11/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
4.5%
17/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
8.1%
26/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
15.1%
16/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.95%
2/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
1.3%
5/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
3.1%
10/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
5.7%
6/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
6/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
6.6%
14/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
6.0%
23/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
5.9%
19/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
2.8%
3/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Infections and infestations
Urinary tract infection
|
4.7%
10/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.95%
2/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
2.6%
10/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
3.7%
12/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
7.5%
8/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
4/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.95%
2/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
2.6%
10/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
3.4%
11/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
11.3%
12/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Nervous system disorders
Sciatica
|
0.47%
1/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.52%
2/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.31%
1/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
5.7%
6/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.47%
1/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.00%
0/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.26%
1/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
0.62%
2/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
11.3%
12/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
|
Vascular disorders
Hypertension
|
2.3%
5/213 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
3.8%
8/211 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
2.6%
10/382 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
2.2%
7/322 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
8.5%
9/106 • Up to 56 days post last dose in the short-term period or the first dose in the open-label period, whichever occurs first
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER