Trial Outcomes & Findings for Remission in Subjects With Crohn's Disease, 1 Year Phase (NCT NCT00055497)
NCT ID: NCT00055497
Last Updated: 2011-04-11
Results Overview
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
276 participants
Primary outcome timeframe
Week 56
Results posted on
2011-04-11
Participant Flow
276 participants were enrolled in the present study from 53 sites in the United States (US), Canada, Poland, Belgium, the Netherlands, and Czech Republic. The first visit in the present study for the first participant was 28 August 2002 and the final visit for the last participant occurred on 12 January 2005.
Study was rollover of NCT00055523; screening done in NCT00055523. At Week 4 of NCT00055497, 55 remitters at Week 0 and Week 4 of Study NCT00055497 were randomized to DB therapy; 204 non-remitters were assigned to OL adalimumab. 17 discontinued before/at Week 4, included in OL group for Participant Flow and AEs because they were not randomized.
Participant milestones
| Measure |
DB Placebo
Double-blind adalimumab placebo every week.
|
DB Adalimumab 40 mg Every Other Week (Eow)
Double-blind adalimumab 40 mg every other week (injection received every week; placebo received when active drug not received)
|
DB Adalimumab 40 mg Every Week (ew)
Double-blind adalimumab 40 mg every week.
|
OL Adalimumab 40 mg
Open-label adalimumab 40 mg every other week or every week.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
18
|
221
|
|
Overall Study
COMPLETED
|
13
|
16
|
16
|
131
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
2
|
90
|
Reasons for withdrawal
| Measure |
DB Placebo
Double-blind adalimumab placebo every week.
|
DB Adalimumab 40 mg Every Other Week (Eow)
Double-blind adalimumab 40 mg every other week (injection received every week; placebo received when active drug not received)
|
DB Adalimumab 40 mg Every Week (ew)
Double-blind adalimumab 40 mg every week.
|
OL Adalimumab 40 mg
Open-label adalimumab 40 mg every other week or every week.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
1
|
28
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
1
|
15
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
5
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
27
|
|
Overall Study
Administrative Reasons
|
0
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
0
|
11
|
Baseline Characteristics
Remission in Subjects With Crohn's Disease, 1 Year Phase
Baseline characteristics by cohort
| Measure |
DB Placebo
n=18 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
n=19 Participants
|
DB Adalimumab 40 mg Every Week
n=18 Participants
|
OL Adalimumab 40 mg Eow
n=204 Participants
Participants who did not continue at Week 4 are not included in Baseline summary.
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
195 Participants
n=4 Participants
|
249 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
137 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
122 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Week 56Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Outcome measures
| Measure |
DB Placebo
n=18 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
n=19 Participants
|
DB Adalimumab 40 mg Every Week (ew)
n=18 Participants
|
OL Adalimumab 40 mg Eow
|
|---|---|---|---|---|
|
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)
|
6 Participants
|
9 Participants
|
12 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 56Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Last observation carried forward was used for missing data.
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Outcome measures
| Measure |
DB Placebo
n=18 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
n=19 Participants
|
DB Adalimumab 40 mg Every Week (ew)
n=18 Participants
|
OL Adalimumab 40 mg Eow
|
|---|---|---|---|---|
|
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)
Week 56
|
8 Participants
|
15 Participants
|
15 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Outcome measures
| Measure |
DB Placebo
n=18 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
n=19 Participants
|
DB Adalimumab 40 mg Every Week (ew)
n=18 Participants
|
OL Adalimumab 40 mg Eow
n=204 Participants
|
|---|---|---|---|---|
|
Number of Participants Achieving Clinical Remission at Week 24 - NRI
|
7 Participants
|
11 Participants
|
17 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: Week 56Population: Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Outcome measures
| Measure |
DB Placebo
n=204 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
|
DB Adalimumab 40 mg Every Week (ew)
|
OL Adalimumab 40 mg Eow
|
|---|---|---|---|---|
|
Number of OL Participants Achieving Clinical Remission at Week 56 - NRI
|
74 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline of lead-in study to Week 24 and Week 56Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.
A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Outcome measures
| Measure |
DB Placebo
n=18 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
n=19 Participants
|
DB Adalimumab 40 mg Every Week (ew)
n=18 Participants
|
OL Adalimumab 40 mg Eow
n=204 Participants
|
|---|---|---|---|---|
|
Number of Participants Achieving Clinical Response 100 (CR-100) - NRI
Week 24
|
7 Participants
|
11 Participants
|
17 Participants
|
110 Participants
|
|
Number of Participants Achieving Clinical Response 100 (CR-100) - NRI
Week 56
|
6 Participants
|
9 Participants
|
13 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: From Baseline of lead-in study to Week 24 and to Week 56Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-70 not achieved) was used for missing data.
A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Outcome measures
| Measure |
DB Placebo
n=18 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
n=19 Participants
|
DB Adalimumab 40 mg Every Week (ew)
n=18 Participants
|
OL Adalimumab 40 mg Eow
n=204 Participants
|
|---|---|---|---|---|
|
Number of Participants Achieving Clinical Response 70 (CR-70)- NRI
Week 24
|
8 Participants
|
13 Participants
|
17 Participants
|
123 Participants
|
|
Number of Participants Achieving Clinical Response 70 (CR-70)- NRI
Week 56
|
6 Participants
|
9 Participants
|
13 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Last observation carried forward (LOCF) was used for missing data.
Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Outcome measures
| Measure |
DB Placebo
n=18 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
n=19 Participants
|
DB Adalimumab 40 mg Every Week (ew)
n=18 Participants
|
OL Adalimumab 40 mg Eow
n=204 Participants
|
|---|---|---|---|---|
|
Number of Participants Achieving Clinical Remission at Week 24 - LOCF
Week 24
|
7 Participants
|
11 Participants
|
17 Participants
|
82 Participants
|
SECONDARY outcome
Timeframe: Week 56Clinical remission is defined as CDAI score \<150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Outcome measures
| Measure |
DB Placebo
n=204 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
|
DB Adalimumab 40 mg Every Week (ew)
|
OL Adalimumab 40 mg Eow
|
|---|---|---|---|---|
|
Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF
|
93 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Baseline of lead-in study to Week 24 and Week 56Population: Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF was used for missing data.
A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Outcome measures
| Measure |
DB Placebo
n=18 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
n=19 Participants
|
DB Adalimumab 40 mg Every Week (ew)
n=18 Participants
|
OL Adalimumab 40 mg Eow
n=204 Participants
|
|---|---|---|---|---|
|
Number of Participants Achieving CR-100 - LOCF
Week 24
|
7 Participants
|
11 Participants
|
17 Participants
|
110 Participants
|
|
Number of Participants Achieving CR-100 - LOCF
Week 56
|
6 Participants
|
9 Participants
|
13 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: From Baseline of lead-in study to Week 24 and Week 56Population: Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF imputation was used for missing data.
A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score \>/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.
Outcome measures
| Measure |
DB Placebo
n=18 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
n=19 Participants
|
DB Adalimumab 40 mg Every Week (ew)
n=18 Participants
|
OL Adalimumab 40 mg Eow
n=204 Participants
|
|---|---|---|---|---|
|
Number of Participants Achieving CR-70 - LOCF
Week 24
|
15 Participants
|
18 Participants
|
17 Participants
|
144 Participants
|
|
Number of Participants Achieving CR-70 - LOCF
Week 56
|
13 Participants
|
15 Participants
|
16 Participants
|
147 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline of lead-in study to Week 24 and Week 56Population: Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. OL adalimumab group was all participants assigned to the OL treatment who continued past Week 4. LOCF was used for missing data. 4 participants in OL group did not have IBDQ data at Baseline of lead-in study.
IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality on the item (e.g., feeling of fatigue "none of the time"). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life.
Outcome measures
| Measure |
DB Placebo
n=18 Participants
|
DB Adalimumab 40 mg Every Other Week (Eow)
n=19 Participants
|
DB Adalimumab 40 mg Every Week (ew)
n=18 Participants
|
OL Adalimumab 40 mg Eow
n=200 Participants
|
|---|---|---|---|---|
|
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF
Week 24
|
29.9 Scores on a scale
Interval 11.0 to 48.9
|
43.4 Scores on a scale
Interval 27.7 to 59.2
|
51.9 Scores on a scale
Interval 30.8 to 73.0
|
33.9 Scores on a scale
Interval 29.7 to 38.1
|
|
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF
Week 56
|
24.7 Scores on a scale
Interval 0.7 to 48.7
|
45.7 Scores on a scale
Interval 27.1 to 64.4
|
45.2 Scores on a scale
Interval 23.1 to 67.4
|
36.0 Scores on a scale
Interval 31.3 to 40.6
|
Adverse Events
DB Placebo
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
DB Adalimumab 40 mg Eow
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
DB Adalimumab 40 mg ew
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
OL Adalimumab 40 mg
Serious events: 37 serious events
Other events: 190 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DB Placebo
n=18 participants at risk
|
DB Adalimumab 40 mg Eow
n=19 participants at risk
|
DB Adalimumab 40 mg ew
n=18 participants at risk
|
OL Adalimumab 40 mg
n=221 participants at risk
|
|---|---|---|---|---|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Abscess
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Abscess intestinal
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Blood and lymphatic system disorders
Anemia NOS aggravated
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Renal and urinary disorders
Calculus renal
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Vascular disorders
Cerebrovascular accident
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
4.1%
9/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Diverticulitis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Nervous system disorders
Dizziness (excl vertigo)
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Fatigue
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Fifth disease
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Ileal stenosis
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc herniation
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Intestinal stenosis NOS
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Nocardiosis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Pain
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Pyloric stenosis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Rectal abscess
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Retroperitoneal abscess
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Sepsis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Small intestinal stricture
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Sweating increased
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
Other adverse events
| Measure |
DB Placebo
n=18 participants at risk
|
DB Adalimumab 40 mg Eow
n=19 participants at risk
|
DB Adalimumab 40 mg ew
n=18 participants at risk
|
OL Adalimumab 40 mg
n=221 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
4.1%
9/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Abdominal pain aggravated
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
3.2%
7/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
10.5%
2/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
6.8%
15/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
4.5%
10/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Anal fissure
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Psychiatric disorders
Anxiety aggravated
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
10.5%
2/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
12.2%
27/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
6.3%
14/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Chest tightness aggravated
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.4%
12/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
3.6%
8/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Crohn's disease aggravated
|
27.8%
5/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
21.1%
4/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
17.6%
39/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
4.5%
10/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Nervous system disorders
Dizziness (excl vertigo)
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
3.2%
7/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Dyspepsia
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.0%
11/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
3.2%
7/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.8%
4/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Fatigue
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
7.2%
16/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Nervous system disorders
Headache
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
14.0%
31/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Influenza
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
15.8%
3/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
6.3%
14/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Injection site oedema
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Injection site reaction
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.0%
11/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Psychiatric disorders
Insomnia
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.4%
12/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
10.5%
2/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
3.6%
8/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
3.2%
7/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Nasopharyngitis
|
38.9%
7/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
26.3%
5/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
16.7%
37/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
10.5%
2/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
10.4%
23/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Pharyngolaryngeal pain
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
10.5%
2/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.0%
11/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Pain in limb
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.0%
11/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.3%
5/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Pyrexia
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
9.5%
21/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
10.5%
2/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
6.8%
15/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
6.3%
14/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.3%
5/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
8.6%
19/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Urinary tract infection
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.9%
13/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Viral infection
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
21.1%
4/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.7%
6/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
6.8%
15/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.3%
5/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Cardiac disorders
Sinus bradycardia
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Eye disorders
Conjunctivitis
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
4.1%
9/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Eye disorders
Episcleritis
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Eye disorders
Iritis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Eye disorders
Pterygium
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Eye disorders
Vision abnormal
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
3/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
9.0%
20/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Anal inflammation
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Anal skin tags
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Anal ulcer
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Faecal incontinence
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Mouth ulceration
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.3%
5/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Oesophageal pain
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Proctalgia
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Tooth impacted
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Adverse drug reaction
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Application site pain
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Asthenia
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Axillary mass
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Bloody drainage
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Fall
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Fatigue aggravated
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Ill-defined disorder
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Influenza like illness
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
4.1%
9/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Malaise
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Oedema
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.3%
5/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Pain
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.7%
6/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Tenderness
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.8%
4/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Abscess
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Arthropod infestation
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Bronchitis acute
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.3%
5/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Cellulitis
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Dry socket
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Folliculitis
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.8%
4/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Ear infection
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Fungal infection
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.7%
6/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Herpes simplex
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
3.6%
8/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Otitis media
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Pathogen resistance
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Pharyngitis streptococcal
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Sinusitis
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
21.1%
4/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
9.0%
20/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Vaginal abscess
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Vaginal candidiasis
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Wound infection
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Injury, poisoning and procedural complications
Abrasion
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
10.5%
2/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
10.5%
2/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Investigations
Antinuclear factor positive
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.3%
5/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Investigations
Blood creatine phophokinase increased
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.8%
4/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Investigations
Double-stranded DNA antibody
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Investigations
Eosinophil count increased
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Investigations
Liver function tests abnormal
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Investigations
Lymphocyte morphology abnormal
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Investigations
Monocyte count increased
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Investigations
Neutrophil count increased
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Investigations
Platelet count decreased
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Investigations
White blood cell count decreased
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Arthritis enteropathic
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.8%
4/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Polyarthralgia
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Sciatica aggravated
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint disorder
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Metabolism and nutrition disorders
Diabetes mellitus aggravated
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Musculoskeletal and connective tissue disorders
Dystrophic calcification
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia aggravated
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Nervous system disorders
Headache aggravated
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.8%
4/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Nervous system disorders
Sleep apnoea syndrome
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Psychiatric disorders
Acute stress disorder
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Psychiatric disorders
Adjustment disorder
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.3%
5/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Psychiatric disorders
Insomnia exacerbated
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Psychiatric disorders
Sleep disorder
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Renal and urinary disorders
Difficulty in micturition
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
3.2%
7/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Reproductive system and breast disorders
Nipple pain
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive airways disease
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
3.2%
7/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
10.5%
2/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal passage irritation
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.8%
4/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Acrochordons
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
2.3%
5/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Skin desquamation
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Skin nodule
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.90%
2/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Surgical and medical procedures
Continuous positive airway pressure
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Surgical and medical procedures
Endodontic procedure
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Surgical and medical procedures
Vasectomy
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Vascular disorders
Ecchymosis
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Vascular disorders
Petechiae
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
General disorders
Mass
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.45%
1/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.8%
4/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Infections and infestations
Pharyngitis
|
11.1%
2/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.3%
1/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
1.4%
3/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous nodule
|
0.00%
0/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/19 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
5.6%
1/18 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
0.00%
0/221 • Safety was measured from the first dose of adalimumab, which could have occurred in the lead-in study, NCT00055523, or in NCT00055497 for participants randomized to placebo in the lead-in study.
Events were summarized from Week 0 of NCT00055523, for participants who entered NCT00055497, to Week 56 of NCT00055497. Treatment-emergent AEs=(1) AEs that began on/after 1st study drug dose in Study NCT00055497 and within 70 days after last dose; or (2) increased severity of ongoing AEs that began on/after 1st study drug dose in Study NCT00055523.
|
Additional Information
Global Medical Services
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Phone: 800-633-9110
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