Trial Outcomes & Findings for A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis (NCT NCT01166282)
NCT ID: NCT01166282
Last Updated: 2021-07-12
Results Overview
A joint assessment was recorded at all study visits to assess the number of active joints. A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Total possible scores ranges from 0 (no active joints) to 72 (all active joints). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
46 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-07-12
Participant Flow
The study included a 30-day screening period.
Participant milestones
| Measure |
Double-blind Placebo EOW
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Open-label Adalimumab EOW
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.
|
|---|---|---|---|
|
Double-blind Period
STARTED
|
15
|
31
|
0
|
|
Double-blind Period
COMPLETED
|
15
|
31
|
0
|
|
Double-blind Period
NOT COMPLETED
|
0
|
0
|
0
|
|
Open-label Period
STARTED
|
0
|
0
|
46
|
|
Open-label Period
COMPLETED
|
0
|
0
|
29
|
|
Open-label Period
NOT COMPLETED
|
0
|
0
|
17
|
Reasons for withdrawal
| Measure |
Double-blind Placebo EOW
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Open-label Adalimumab EOW
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.
|
|---|---|---|---|
|
Open-label Period
Adverse Event
|
0
|
0
|
6
|
|
Open-label Period
Withdrawal by Subject
|
0
|
0
|
4
|
|
Open-label Period
Lack of Efficacy
|
0
|
0
|
2
|
|
Open-label Period
Remission
|
0
|
0
|
4
|
|
Open-label Period
Irregular Compliance
|
0
|
0
|
1
|
Baseline Characteristics
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
Baseline characteristics by cohort
| Measure |
Double-blind Placebo EOW
n=15 Participants
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 Participants
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.9 years
STANDARD_DEVIATION 2.85 • n=5 Participants
|
13.4 years
STANDARD_DEVIATION 2.86 • n=7 Participants
|
12.9 years
STANDARD_DEVIATION 2.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: ITT population
A joint assessment was recorded at all study visits to assess the number of active joints. A total of 72 joints were assessed for swelling not due to deformity or joints with loss of motion (LOM) plus pain and/or tenderness. Total possible scores ranges from 0 (no active joints) to 72 (all active joints). Baseline is defined as the last nonmissing value prior to the first dose of study drug. Last Observation Carried Forward (LOCF) was used for missing data.
Outcome measures
| Measure |
Double-blind Placebo EOW
n=15 Participants
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 Participants
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Any Adalimumab
All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
|
|---|---|---|---|
|
Percent Change in Number of Active Joints With Arthritis From Baseline to Week 12
|
-11.6 percent change
Standard Deviation 100.5
|
-62.6 percent change
Standard Deviation 59.53
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population
The presence of enthesitis was assessed by pressure at 35 anatomical locations. Enthesitis was classifed as either present or absent. Scores range from 0 to 35, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.
Outcome measures
| Measure |
Double-blind Placebo EOW
n=15 Participants
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 Participants
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Any Adalimumab
All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
|
|---|---|---|---|
|
Number of Sites of Enthesitis: Change From Baseline to Week 12
Change from Baseline to Week 12
|
-2.7 sites of enthesitis
Standard Deviation 4.98
|
-4.4 sites of enthesitis
Standard Deviation 6.20
|
—
|
|
Number of Sites of Enthesitis: Change From Baseline to Week 12
Baseline
|
7.8 sites of enthesitis
Standard Deviation 7.49
|
8.3 sites of enthesitis
Standard Deviation 8.89
|
—
|
|
Number of Sites of Enthesitis: Change From Baseline to Week 12
Week 12
|
5.1 sites of enthesitis
Standard Deviation 8.92
|
3.9 sites of enthesitis
Standard Deviation 6.60
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population
Seventy-two joints were assessed by pressure on physical examination. Joint tenderness was classified as either present or absent. Scores range from 0 to 72, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.
Outcome measures
| Measure |
Double-blind Placebo EOW
n=15 Participants
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 Participants
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Any Adalimumab
All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
|
|---|---|---|---|
|
Tender Joint Count (TJC72): Change From Baseline to Week 12
Baseline
|
11.9 units on a scale
Standard Deviation 9.34
|
13.4 units on a scale
Standard Deviation 10.49
|
—
|
|
Tender Joint Count (TJC72): Change From Baseline to Week 12
Week 12
|
7.5 units on a scale
Standard Deviation 8.06
|
5.5 units on a scale
Standard Deviation 8.77
|
—
|
|
Tender Joint Count (TJC72): Change From Baseline to Week 12
Change from Baseline to Week 12
|
-4.5 units on a scale
Standard Deviation 8.97
|
-7.9 units on a scale
Standard Deviation 8.25
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population
Sixty-eight joints were assessed by physical examination. Joint swelling was classified as present or absent. Scores range from 0 to 68, with higher scores representing higher disease activity. Baseline is defined as the last nonmissing value prior to the first dose of study drug. LOCF was used.
Outcome measures
| Measure |
Double-blind Placebo EOW
n=15 Participants
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 Participants
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Any Adalimumab
All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
|
|---|---|---|---|
|
Swollen Joint Count (SJC68): Change From Baseline to Week 12
Week 12
|
2.8 units on a scale
Standard Deviation 2.83
|
3.2 units on a scale
Standard Deviation 7.27
|
—
|
|
Swollen Joint Count (SJC68): Change From Baseline to Week 12
Change from Baseline to Week 12
|
-2.4 units on a scale
Standard Deviation 4.66
|
-3.5 units on a scale
Standard Deviation 5.61
|
—
|
|
Swollen Joint Count (SJC68): Change From Baseline to Week 12
Baseline
|
5.2 units on a scale
Standard Deviation 3.69
|
6.7 units on a scale
Standard Deviation 7.30
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population
The ACR Pedi30 response is defined as ≥30% improvement in at least 3 of 6 juvenile rheumatoid arthritis (JRA) core set criteria with no more than 1 of the 6 criteria with \>30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation (NRI) was used for missing data.
Outcome measures
| Measure |
Double-blind Placebo EOW
n=15 Participants
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 Participants
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Any Adalimumab
All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 30% Response (ACR Pedi30)
|
60.0 percentage of participants
|
71.0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population
The ACR Pedi50 response is defined as ≥50% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with \>30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. NRI was used.
Outcome measures
| Measure |
Double-blind Placebo EOW
n=15 Participants
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 Participants
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Any Adalimumab
All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 50% Response (ACR Pedi50)
|
40.0 percentage of participants
|
67.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: ITT population
The ACR Pedi70 response is defined as ≥70% improvement in at least 3 of 6 JRA core set criteria with no more than 1 of the 6 criteria with \>30% worsening. The 6 variables for the JRA core set criteria are Physician's Global Assessment (PGA) of participant's disease activity, Parent's Global Assessment of participant's overall well-being, number of active joints (joints with swelling not due to deformity or joints LOM plus pain and/or tenderness), number of joints with LOM, Childhood Health Assessment Questionnaire (CHAQ), and high sensitivity C-reactive protein (hs CRP). Baseline is the last value prior to the first dose of study drug. Non-responder imputation NRI was used.
Outcome measures
| Measure |
Double-blind Placebo EOW
n=15 Participants
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 Participants
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Any Adalimumab
All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
|
|---|---|---|---|
|
Percentage of Participants Achieving Pediatric American College of Rheumatology Pediatric 70% Response (ACR Pedi70)
|
20.0 percentage of participants
|
54.8 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks)Population: Safety population: All randomized subjects who received at least 1 dose of study drug
An AE is any untoward medical occurrence in a participant which does not necessarily have a causal relationship with this treatment. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs or TESAE) are defined as any event that began or worsened in severity after the first dose of study drug. The investigator assessed the relationship of each event to the use of study drug as either probably related to study drug, possibly related to study drug, probably not related, or not related to study drug. For more details on adverse events please see the AE section below.
Outcome measures
| Measure |
Double-blind Placebo EOW
n=15 Participants
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 Participants
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Any Adalimumab
n=46 Participants
All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any TEAE Leading to Discontinuation of Study
|
0 participants
|
0 participants
|
7 participants
|
|
Number of Participants With Adverse Events (AEs)
Death
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs)
Any TEAE
|
8 participants
|
21 participants
|
46 participants
|
|
Number of Participants With Adverse Events (AEs)
TEAEs at least possibly related to study drug
|
4 participants
|
9 participants
|
29 participants
|
|
Number of Participants With Adverse Events (AEs)
Any severe TEAE
|
0 participants
|
0 participants
|
7 participants
|
|
Number of Participants With Adverse Events (AEs)
TESAE
|
0 participants
|
1 participants
|
10 participants
|
Adverse Events
Double-blind Placebo EOW
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Double-blind Adalimumab EOW
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Any Adalimumab
Serious events: 10 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Double-blind Placebo EOW
n=15 participants at risk
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 participants at risk
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Any Adalimumab
n=46 participants at risk
All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
|
|---|---|---|---|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
PAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
DISSEMINATED TUBERCULOSIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
BURNS SECOND DEGREE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
BURNS THIRD DEGREE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Investigations
TUBERCULIN TEST POSITIVE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
JOINT INSTABILITY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
JUVENILE IDIOPATHIC ARTHRITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Vascular disorders
DIFFUSE VASCULITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
Other adverse events
| Measure |
Double-blind Placebo EOW
n=15 participants at risk
Placebo for adalimumab every other week (eow) for 12 weeks.
|
Double-blind Adalimumab EOW
n=31 participants at risk
Adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
|
Any Adalimumab
n=46 participants at risk
All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m\^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
|
|---|---|---|---|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
15.2%
7/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
PHARYNGOTONSILLITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
15.2%
7/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
PILONIDAL CYST
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
RASH PUSTULAR
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
RHINITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
ROTAVIRUS INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
SCARLET FEVER
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
SINUSITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
10.9%
5/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
TINEA INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
TINEA PEDIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
TONSILLITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
8.7%
4/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
TONSILLITIS BACTERIAL
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
TRACHEITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Nervous system disorders
DISTURBANCE IN ATTENTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
13.3%
2/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
9.7%
3/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
34.8%
16/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
VARICELLA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
VIRAL TONSILLITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
9.7%
3/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
21.7%
10/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
8.7%
4/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
LIP INJURY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
SKELETAL INJURY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
TOOTH FRACTURE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMORRHAGE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
9.7%
3/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
10.9%
5/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Investigations
BONE DENSITY DECREASED
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Investigations
TRANSAMINASES INCREASED
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
2/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
8.7%
4/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Metabolism and nutrition disorders
HYPERTRIGLYCERIDAEMIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Nervous system disorders
TREMOR
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Metabolism and nutrition disorders
METABOLIC SYNDROME
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
GROWING PAINS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
JUVENILE IDIOPATHIC ARTHRITIS
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
13.0%
6/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
OSTEOCHONDROSIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Blood and lymphatic system disorders
INCREASED TENDENCY TO BRUISE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Eye disorders
ASTIGMATISM
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Eye disorders
CATARACT
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Eye disorders
CONJUNCTIVITIS ALLERGIC
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Eye disorders
DRY EYE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
13.0%
6/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
2/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
ANAL FISSURE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
8.7%
4/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
17.4%
8/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
NAUSEA
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
2/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
10.9%
5/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
ODYNOPHAGIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
8.7%
4/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
ADVERSE DRUG REACTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
FATIGUE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
INFLAMMATION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
INJECTION SITE PAIN
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
9.7%
3/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
10.9%
5/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
INJECTION SITE PRURITUS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
INJECTION SITE URTICARIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
PAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
PERIPHERAL SWELLING
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
General disorders
PYREXIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
13.0%
6/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Hepatobiliary disorders
HEPATOCELLULAR INJURY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Immune system disorders
ALLERGY TO ARTHROPOD BITE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
ABSCESS LIMB
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
ACARODERMATITIS
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
BRONCHITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
10.9%
5/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
CANDIDA INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
CONJUNCTIVITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
CYSTITIS
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
EAR INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
FOLLICULITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
2/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
17.4%
8/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
GASTROINTESTINAL INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
HERPES ZOSTER
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
LARYNGITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
LATENT TUBERCULOSIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
NASOPHARYNGITIS
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
23.9%
11/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
8.7%
4/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
ORCHITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
OTITIS MEDIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
8.7%
4/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
OTITIS MEDIA ACUTE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
OTITIS MEDIA CHRONIC
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Infections and infestations
PARONYCHIA
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Psychiatric disorders
ATTENTION DEFICIT/HYPERACTIVITY DISORDER
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Psychiatric disorders
DEPRESSION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Psychiatric disorders
SLEEP DISORDER
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Psychiatric disorders
TIC
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Renal and urinary disorders
IGA NEPHROPATHY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Renal and urinary disorders
LEUKOCYTURIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Reproductive system and breast disorders
GYNAECOMASTIA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Reproductive system and breast disorders
PENIS DISORDER
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Reproductive system and breast disorders
SCROTAL PAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Reproductive system and breast disorders
VARICOCELE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
ADENOIDAL HYPERTROPHY
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
8.7%
4/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
6.5%
3/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
TONSILLAR INFLAMMATION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Respiratory, thoracic and mediastinal disorders
VASOMOTOR RHINITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ALLERGIC
|
6.7%
1/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
8.7%
4/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
KERATOSIS PILARIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
PITYRIASIS ROSEA
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
PUSTULAR PSORIASIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
4.3%
2/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
RASH ERYTHEMATOUS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
3.2%
1/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
SKIN EXFOLIATION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Skin and subcutaneous tissue disorders
SOLAR DERMATITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Vascular disorders
PREHYPERTENSION
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Vascular disorders
RAYNAUD'S PHENOMENON
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
|
Vascular disorders
VASCULITIS
|
0.00%
0/15 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
0.00%
0/31 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
2.2%
1/46 • Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 212 weeks); SAEs were collected from the time informed consent was obtained (up to 216 weeks).
A TEAE is defined as events with onset or worsening after the first dose of study drug to the first dose of open-label (OL) adalimumab (double blind \[DB\] period only), or 70 days following the last study drug administration or until the first dose of commercially available Humira after completion of the study, whichever occurs first.
|
Additional Information
Global Medical Information
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