Trial Outcomes & Findings for Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate. (NCT NCT00195702)
NCT ID: NCT00195702
Last Updated: 2011-08-26
Results Overview
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
619 participants
Primary outcome timeframe
Week 24
Results posted on
2011-08-26
Participant Flow
Subjects were enrolled at 95 sites in the United States and Canada between February 2000 and August 2001.
Eligible subjects who were taking disease-modifying anti-rheumatic drugs (DMARDs) other than methotrexate (MTX) entered a 4- to 6-week washout period, during which previous DMARDs (except MTX) were discontinued. Subjects who were not taking DMARDs, other than MTX, entered directly into the 52-week double-blind treatment period of the study.
Participant milestones
| Measure |
DB Adalimumab 20 mg ew
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow
Subjects received adalimumab 20 mg weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
|
DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
|
DB Placebo ew/OL Adalimumab 40 mg Eow
Subjects received placebo weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
|
|---|---|---|---|---|---|---|
|
Double-blind Phase
STARTED
|
212
|
207
|
200
|
0
|
0
|
0
|
|
Double-blind Phase
COMPLETED
|
168
|
159
|
140
|
0
|
0
|
0
|
|
Double-blind Phase
NOT COMPLETED
|
44
|
48
|
60
|
0
|
0
|
0
|
|
Open-label Extension Phase
STARTED
|
0
|
0
|
0
|
165
|
158
|
134
|
|
Open-label Extension Phase
COMPLETED
|
0
|
0
|
0
|
66
|
80
|
56
|
|
Open-label Extension Phase
NOT COMPLETED
|
0
|
0
|
0
|
99
|
78
|
78
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Adalimumab in Patients With Active Rheumatoid Arthritis Treated Concomitantly With Methotrexate.
Baseline characteristics by cohort
| Measure |
DB Adalimumab 20 mg ew
n=212 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=207 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=200 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
Total
n=619 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 40 years
|
10 participants
n=5 Participants
|
27 participants
n=7 Participants
|
18 participants
n=5 Participants
|
55 participants
n=4 Participants
|
|
Age, Customized
Between 40 and 64 years
|
150 participants
n=5 Participants
|
115 participants
n=7 Participants
|
137 participants
n=5 Participants
|
402 participants
n=4 Participants
|
|
Age, Customized
Between 65 and 74 years
|
41 participants
n=5 Participants
|
54 participants
n=7 Participants
|
35 participants
n=5 Participants
|
130 participants
n=4 Participants
|
|
Age, Customized
>= 75 years
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
32 participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
160 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
464 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
155 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=212 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=207 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=200 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 24
|
129 Participants
|
131 Participants
|
59 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 24 or early termination.
Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=196 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=183 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=172 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Change From Baseline in Modified Total Sharp X-ray Score at Week 52
|
0.8 Units on a scale
Standard Deviation 4.9 • Interval -14.5 to 50.5
|
0.1 Units on a scale
Standard Deviation 4.8 • Interval -37.0 to 23.5
|
2.7 Units on a scale
Standard Deviation 6.8 • Interval -25.0 to 39.0
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Last observation carried forward (LOCF) data analysis was used for missing values.
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=212 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=204 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=198 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 52
|
-0.61 Units on a scale
Standard Deviation 0.55
|
-0.59 Units on a scale
Standard Deviation 0.57
|
-0.25 Units on a scale
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Week 52Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=212 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=207 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=200 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants Meeting ACR20 Response Criteria at Week 52
|
116 Participants
|
122 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline using data collected at baseline and Week 52.
Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 24. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=196 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=183 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=172 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Change From Baseline in Modified Total Sharp X-ray Score at Week 24
|
0.6 Units on a scale
Standard Deviation 4.9
|
0.3 Units on a scale
Standard Deviation 4.5
|
1.3 Units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. LOCF data analysis was used for missing values.
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=212 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=204 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=198 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 24
|
-0.60 Units on a scale
Standard Deviation 0.53
|
-0.56 Units on a scale
Standard Deviation 0.52
|
-0.24 Units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Week 52Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were responders at Week 12 or 24 were evaluated to determine whether the response was maintained. LOCF data analysis was used for missing values.
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Responders had a \>= 0.22-unit decrease (improvement) in HAQ scores from baseline to Week 12 or 24.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=212 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=207 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=200 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24
Maintained Response
|
130 Participants
|
121 Participants
|
73 Participants
|
|
Maintenance of the Disability Index of the HAQ at Week 52 for Participants Who Were Responders at Week 12 or Week 24
Did Not Maintain Response
|
7 Participants
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Week 52Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Subjects who were ACR20 responders at Week 24 were evaluated to determine whether the response was maintained. Observed data were analyzed.
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=129 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=131 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=59 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24
Maintained Response
|
99 Participants
|
111 Participants
|
32 Participants
|
|
Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24
Did Not Maintain Response
|
21 Participants
|
12 Participants
|
23 Participants
|
|
Maintenance of ACR20 Response at Week 52 for Participants Who Were ACR20 Responders at Week 24
Missing
|
9 Participants
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed.
Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=212 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=207 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=200 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants With a Continuous ACR70 Response for 6 Months During 52 Weeks of Treatment
|
20 Participants
|
18 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR20 response criteria for the first time at each time point is presented.
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=212 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=207 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=200 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 24
|
2 Participants
|
2 Participants
|
7 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Non-responder
|
25 Participants
|
29 Participants
|
81 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 2
|
69 Participants
|
53 Participants
|
26 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 4
|
48 Participants
|
48 Participants
|
30 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 8
|
29 Participants
|
33 Participants
|
21 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 12
|
17 Participants
|
23 Participants
|
14 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 16
|
7 Participants
|
8 Participants
|
12 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 20
|
8 Participants
|
7 Participants
|
3 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 32
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 40
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 48
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Time to First Response According to ACR20 Criteria - Number of Participants Meeting ACR20 Criteria for the First Time at Each Time Point
Week 52
|
2 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR50 response criteria for the first time at each time point is presented.
Patients were responders if they had: \>= 50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=212 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=207 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=200 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Non-responder
|
71 Participants
|
69 Participants
|
135 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 2
|
18 Participants
|
13 Participants
|
4 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 4
|
17 Participants
|
26 Participants
|
6 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 8
|
26 Participants
|
25 Participants
|
6 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 12
|
25 Participants
|
21 Participants
|
10 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 16
|
23 Participants
|
21 Participants
|
8 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 20
|
16 Participants
|
10 Participants
|
9 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 24
|
7 Participants
|
7 Participants
|
3 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 32
|
4 Participants
|
7 Participants
|
8 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 40
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 48
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Time to First Response According to ACR50 Criteria - Number of Participants Meeting ACR50 Criteria for the First Time at Each Time Point
Week 52
|
1 Participants
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline through Week 52Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Observed data were analyzed. The number of subjects meeting ACR70 response criteria for the first time at each time point is presented.
Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=212 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=207 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=200 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Non-responder
|
126 Participants
|
120 Participants
|
177 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 16
|
15 Participants
|
9 Participants
|
1 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 20
|
9 Participants
|
11 Participants
|
2 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 24
|
4 Participants
|
11 Participants
|
2 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 2
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 4
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 8
|
11 Participants
|
7 Participants
|
1 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 12
|
14 Participants
|
16 Participants
|
2 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 32
|
9 Participants
|
8 Participants
|
3 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 40
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 48
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Time to First Response According to ACR70 Criteria - Number of Participants Meeting ACR70 Criteria for the First Time at Each Time Point
Week 52
|
6 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Full analysis set, defined as all subjects who were randomized and received at least one injection of study drug. Missing values were imputed via linear extrapolation from baseline.
Estimated yearly progression was defined as modified total Sharp x-ray score at baseline divided by duration of rheumatoid arthritis disease at baseline. Actual progression during the study was defined as modified total Sharp x-ray score at Week 52 minus modified total Sharp x-ray score at baseline divided by the duration of the study. The range of scores for the modified total Sharp x-ray score was 0 (normal) to 398 (maximal disease).
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=200 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=194 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=184 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Estimated Yearly Progression of Rheumatoid Arthritis
Estimated yearly progression
|
11.11 Units on a scale
Standard Deviation 16.75
|
9.46 Units on a scale
Standard Deviation 10.42
|
9.97 Units on a scale
Standard Deviation 12.84
|
|
Estimated Yearly Progression of Rheumatoid Arthritis
Actual progression during study
|
0.77 Units on a scale
Standard Deviation 4.90
|
0.09 Units on a scale
Standard Deviation 4.75
|
2.66 Units on a scale
Standard Deviation 6.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) GroupPopulation: Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.
Gender (female/male) recorded at Baseline for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=553 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)
Female
|
413 participants
|
—
|
—
|
|
Baseline Measure: Gender - Female/Male - for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)
Male
|
140 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline for Intent-to-Treat (Any Adalimumab Through Year 10) GroupPopulation: Participants in the Any Adalimumab Through Year 10 group are intent-to-treat subjects.
Age recorded at Baseline, reported by category, for the Intent-to-Treat population (the Any Adalimumab Through Year 10 group) of the study. This measure was not included in the Baseline Characteristics section due to the difficulty of maintaining correct subject numbers and totals in that section.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=553 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)
< 40 years
|
50 participants
|
—
|
—
|
|
Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)
Between 40 and 64 years
|
361 participants
|
—
|
—
|
|
Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)
Between 65 and 74 years
|
117 participants
|
—
|
—
|
|
Baseline Measure: Age Categories for the Any Adalimumab Through Year 10 Group (Intent-to-Treat)
>= 75 years
|
25 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 260Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed as observed (without imputation).
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=290 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants Meeting American College of Rheumatology 20% (ACR20) Response Criteria at Week 260
|
200 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 520Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (without imputation).
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=148 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants Meeting the American College of Rheumatology 20% (ACR20) Response Criteria at Week 520
|
115 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 260Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).
Patients were responders if they had: \>= 50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=290 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants Meeting American College of Rheumatology 50% (ACR50) Response Criteria at Week 260
|
153 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 520Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).
Patients were responders if they had: \>= 50% improvement in tender joint count; \>= 50% improvement in swollen joint count; and \>= 50% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=148 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants Meeting the American College of Rheumatology 50% (ACR50) Response Criteria at Week 520
|
100 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 260Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).
Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=290 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 260
|
87 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 520Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. All analyses were performed using data as observed (no imputation).
Patients were responders if they had: \>= 70% improvement in tender joint count; \>= 70% improvement in swollen joint count; and \>= 70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=148 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants Meeting the American College of Rheumatology 70% (ACR70) Response Criteria at Week 520
|
78 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Week 520Population: Participants analyzed were intent-to-treat subjects with non-missing response. Analyses were performed using data as observed (no imputation).
Patients were responders if they had: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=535 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants With a Continuous American College of Rheumatology 70% (ACR70) Response for at Least 6 Months Through Year 10
|
159 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 260Population: Participants analyzed were intent-to-treat with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).
The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=300 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 260
|
205 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 520Population: Participants analyzed were intent-to-treat subjects with non-missing response who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).
The Health Assessment Questionnaire (HAQ) Disability Index is a self-reported measure of disability, which assesses the patient's ability to perform the following tasks: dress and groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity. Possible responses/scores are 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). Negative mean changes from Baseline indicate improvement. An improvement of 0.22 in score (a -0.22 or greater reduction from Baseline score) is a minimally clinically significant change.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=149 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Number of Participants With at Least a 0.22 Reduction From Baseline in the Health Assessment Questionnaire (HAQ) Disability Index at Week 520
|
110 participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 260Population: Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=300 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 260
|
-0.56 units on a scale
Standard Deviation 0.62
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 520Population: Participants analyzed were intent-to-treat subjects with non-missing change who remained in the study. Baseline was the last non-missing value prior to the first injection of adalimumab. Analyses were performed using data as observed (no imputation).
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3)eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores were: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from Baseline in the disability index of the HAQ indicated improvement.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=149 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ) at Week 520
|
-0.62 units on a scale
Standard Deviation 0.60
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 416Population: Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).
Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 416. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=70 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=81 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=53 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Change From Baseline in Modified Total Sharp X-ray Score at Week 416
|
1.16 units on a scale
Standard Deviation 7.969
|
0.14 units on a scale
Standard Deviation 9.310
|
4.83 units on a scale
Standard Deviation 10.012
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 520Population: Participants in each of the three groups were randomized subjects with non-missing radiographs who remained in the study. Baseline was defined as the value at the first visit. Analyses were performed using data as observed (no imputation).
Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 520. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.
Outcome measures
| Measure |
DB Adalimumab 20 mg ew
n=70 Participants
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=79 Participants
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=54 Participants
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
|---|---|---|---|
|
Change From Baseline in Modified Total Sharp X-ray Score at Week 520
|
2.60 units on a scale
Standard Deviation 8.822
|
0.72 units on a scale
Standard Deviation 10.430
|
6.18 units on a scale
Standard Deviation 12.071
|
Adverse Events
DB Adalimumab 20 mg ew
Serious events: 34 serious events
Other events: 167 other events
Deaths: 0 deaths
DB Adalimumab 40 mg Eow
Serious events: 27 serious events
Other events: 148 other events
Deaths: 0 deaths
DB Placebo ew
Serious events: 20 serious events
Other events: 149 other events
Deaths: 0 deaths
Any Adalimumab Through Year 10
Serious events: 271 serious events
Other events: 511 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Adalimumab 20 mg ew
n=212 participants at risk
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=207 participants at risk
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=200 participants at risk
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
Any Adalimumab Through Year 10
n=553 participants at risk
Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.0%
2/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
2.4%
13/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.3%
7/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Investigations
Blood pressure increased
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.90%
5/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.1%
6/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.90%
5/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cardiac myxoma
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Cardiac pacemaker malfunction
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Chemical poisoning
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Chest pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.72%
4/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Cholecystectomy
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Hepatobiliary disorders
Cholestasis
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.72%
4/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.3%
7/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.1%
6/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Psychiatric disorders
Depression
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.72%
4/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Escherichia sepsis
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.94%
2/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.1%
6/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Gastroenteritis viral
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.3%
7/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Histoplasmosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.90%
5/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Hysterectomy
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Infected skin ulcer
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Immune system disorders
Iodine allergy
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Joint dislocation postoperative
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.94%
2/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Multiple sclerosis
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.8%
10/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.1%
6/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.97%
2/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Paraesthesia
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Pelvic mass
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Pneumonia
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.9%
4/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
3.6%
20/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Polyarthritis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polycythaemia vera
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testicular seminoma (pure)
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Reproductive system and breast disorders
Postmenopausal haemorrhage
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.90%
5/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.90%
5/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Renal and urinary disorders
Renal vessel disorder
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.94%
2/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.3%
35/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Septic shock
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Immune system disorders
Serum sickness
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.50%
1/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Toe operation
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Tremor
|
0.47%
1/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.48%
1/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Congenital, familial and genetic disorders
Cardiac septal defect
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Enterocele
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Gastrititis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Gastrointestinal heamorrhage
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Intestinal infarction
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Intestinal ulcer perforation
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Cyst rupture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Death
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Device dislocation
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Multi-organ failure
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Pyrexia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Sudden death
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Ulcer haemorrhage
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.90%
5/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Abscess
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Bronchiectasis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
2.7%
15/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Candidiasis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Enterococal infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Haematoma infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Histoplasmosis disseminated
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.3%
7/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Localised infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Sepsis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.72%
4/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Streptococcal infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Back injuury
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.72%
4/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Skin flap necrosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Fracture nonunion
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Hand deformity
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.72%
4/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
3.3%
18/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Sacroiliitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage I
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal carcinoma
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to abdominal cavity
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic gastric cancer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Renal and urinary disorders
Bladder disorder
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Renal and urinary disorders
Bladder prolapse
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian epithelial cancer metastatic
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary tumour benign
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma metastatic
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Syncope
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.72%
4/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.1%
6/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Reproductive system and breast disorders
Pelvic prolapse
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Reproductive system and breast disorders
Rectocele
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Ankle operation
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Breast prosthesis implantation
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Breast reconstruction
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Finger amputation
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Foot operation
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Mastectomy
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Vascular disorders
Angiopathy
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.54%
3/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Vascular disorders
Aortic stenosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.90%
5/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Vascular disorders
Haematoma
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Vascular disorders
Hypotension
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.36%
2/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.18%
1/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
Other adverse events
| Measure |
DB Adalimumab 20 mg ew
n=212 participants at risk
Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
|
DB Adalimumab 40 mg Eow
n=207 participants at risk
Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
DB Placebo ew
n=200 participants at risk
Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
|
Any Adalimumab Through Year 10
n=553 participants at risk
Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.0%
19/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.3%
11/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.5%
15/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
21.7%
120/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
15/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
4.8%
10/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
4.5%
9/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
18.6%
103/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Bronchitis
|
7.5%
16/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
3.4%
7/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.5%
15/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
19.2%
106/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.7%
10/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.7%
16/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.0%
14/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
13.0%
72/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.8%
23/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
9.7%
20/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
15.0%
30/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
17.5%
97/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Dizziness
|
5.2%
11/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
3.4%
7/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.5%
11/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
11.4%
63/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Influenza
|
4.7%
10/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
2.9%
6/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.5%
13/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
14.3%
79/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Nervous system disorders
Headache
|
13.2%
28/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
11.6%
24/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.0%
10/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
17.2%
95/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Vascular disorders
Hypertension
|
5.2%
11/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
4.3%
9/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
2.0%
4/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
21.0%
116/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Injection site pain
|
17.5%
37/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
17.9%
37/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
21.5%
43/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
13.4%
74/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Nausea
|
13.2%
28/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
9.2%
19/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
12.5%
25/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
17.0%
94/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.2%
11/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.3%
11/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
4.0%
8/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
13.9%
77/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Oedema peripheral
|
0.94%
2/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.3%
11/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
3.5%
7/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
13.7%
76/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
12/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.2%
15/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.0%
10/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
15.0%
83/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.2%
11/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.3%
11/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
4.5%
9/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.6%
42/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.8%
8/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
3.9%
8/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
8.5%
17/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
9.2%
51/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.5%
35/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
16.9%
35/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
11.0%
22/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
40.7%
225/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Urinary tract infection
|
7.5%
16/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
8.7%
18/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.5%
15/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
21.3%
118/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
6/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
1.9%
4/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.0%
12/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.6%
42/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Fatigue
|
8.5%
18/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.3%
11/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.5%
15/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
14.3%
79/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Nasopharyngitis
|
10.8%
23/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
11.6%
24/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
9.0%
18/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
21.5%
119/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Sinusitis
|
9.9%
21/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
10.6%
22/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
8.5%
17/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
27.1%
150/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.2%
9/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
3.9%
8/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.0%
10/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
8.0%
44/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
4.7%
10/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.8%
14/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
12.0%
24/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
22.2%
123/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.1%
39/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Eye disorders
Cataract
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
10.7%
59/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Eye disorders
Dry eye
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.6%
31/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.6%
31/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.2%
40/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.3%
35/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
8.5%
47/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
9.2%
51/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
9.4%
52/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
General disorders
Chest pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.6%
42/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.0%
33/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Ear infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.4%
30/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.3%
35/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
9.0%
50/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Localised infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.4%
30/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.2%
29/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.8%
32/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.2%
29/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
8.3%
46/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.3%
35/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.2%
29/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.8%
32/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.9%
38/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.6%
42/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
7.6%
42/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
8.7%
48/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.2%
29/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
8.1%
45/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
8.1%
45/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
9.0%
50/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.8%
32/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.8%
32/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.3%
35/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.3%
35/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.2%
29/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Psychiatric disorders
Depression
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
12.8%
71/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
8.9%
49/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
6.9%
38/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.1%
28/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/212 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/207 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
0.00%
0/200 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
5.8%
32/553 • For the double-blind (DB) phase: Week 0 to Week 52; for the Any Adalimumab Through Year 10 (intent-to-treat [ITT]) group: first adalimumab injection to the last day in Year 10 (for each subject, the day of the last adalimumab injection plus 70 days)
The protocol specified that adverse events (AEs) be summarized by HARTS body system/preferred term (used in the clinical study report and primary publication for the DB phase). AE terms for the DB phase were recoded using MedDRA version 12.1 for purposes of this disclosure. AEs for the Any Adalimumab group were coded using MedDRA version 13.1.
|
Additional Information
Global Medical Services
Abbott
Phone: 800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection
- Publication restrictions are in place
Restriction type: OTHER