Trial Outcomes & Findings for Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806 (NCT NCT00686374)

NCT ID: NCT00686374

Last Updated: 2018-07-02

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

100 participants

Primary outcome timeframe

Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408

Results posted on

2018-07-02

Participant Flow

36 participants discontinued study drug when adalimumab became commercially available (received regulatory approval for pediatric Crohn's disease) in their country. These participants were considered to have completed the study, and are included as study completers in the subject disposition.

Participant milestones

Participant milestones
Measure	Any Adalimumab Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Study STARTED	100
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	61

Reasons for withdrawal

Reasons for withdrawal
Measure	Any Adalimumab Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Overall Study Lack of Efficacy	10
Overall Study Adverse Event	8
Overall Study Withdrew consent	5
Overall Study Lost to Follow-up	1
Overall Study Missing reason	33
Overall Study Other, not specified	4

Baseline Characteristics

Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Any Adalimumab n=100 Participants Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Age, Continuous	13.5 years STANDARD_DEVIATION 2.5 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Race/Ethnicity, Customized White	93 Participants n=5 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants
Race/Ethnicity, Customized Multi-race	2 Participants n=5 Participants
Body weight at Study M06-806 Baseline < 40 kg	38 Participants n=5 Participants
Body weight at Study M06-806 Baseline ≥ 40 kg	62 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408

Population: ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.

Outcome measures

Outcome measures
Measure	Any Adalimumab n=100 Participants Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 0	67 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 4	65 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 8	67 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 12	60 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 24	59 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 36	60 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 48	54 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 60	60 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 72	49 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 84	54 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 96	54 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 108	54 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 120	52 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 144	51 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 168	44 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 192	44 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 216	36 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 240	37 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 264	31 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 288	24 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 312	14 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 336	8 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 360	7 Participants
Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time Week 384	2 Participants

PRIMARY outcome

Timeframe: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408

Population: ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.

Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The baseline PCDAI value was defined as the last non-missing value on or before the date of the first dose of study drug during Study M06-806. Clinical response was defined as a PCDAI ≥ 15 points lower than the Study M06-806 baseline PCDAI value.

Outcome measures

Outcome measures
Measure	Any Adalimumab n=100 Participants Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 240	43 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 0	95 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 4	90 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 8	92 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 12	87 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 24	88 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 264	35 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 288	28 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 312	15 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 336	10 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 36	82 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 48	74 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 60	76 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 72	72 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 84	69 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 360	8 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 96	72 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 108	70 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 120	65 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 144	64 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 168	53 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 192	52 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 216	46 Participants
Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time Week 384	2 Participants

SECONDARY outcome

Timeframe: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408

Population: Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.

The CDAI includes 8 variables encompassing both subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. For symptoms scores, participants kept track of daily symptoms on a diary card, and the daily symptom scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: \< 150 to indicate remission, 150 - 219 to define mildly active disease, 220 - 450 to define moderately active disease, and \> 450 to define severely active disease. A CDAI was calculated at each visit for participants who were age 13 or older at Study M06-806 entry. The Study M06-806 Week 52 visit served as the baseline visit for this study.

Outcome measures

Outcome measures
Measure	Any Adalimumab n=65 Participants Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 24	54 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 36	52 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 72	47 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 144	40 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 288	17 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 312	15 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 336	8 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 360	7 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 0	58 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 8	58 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 12	53 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 4	55 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 48	48 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 84	46 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 96	45 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 108	45 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 120	42 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 168	35 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 192	31 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 216	27 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 60	49 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 384	1 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 240	26 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time Week 264	23 Participants

SECONDARY outcome

Timeframe: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408

Population: Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.

The CDAI includes 8 variables: subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight). Participants kept track of symptoms on a diary card, and scores were summed for the week. Each item is assigned a specific weight, and the weighted values of the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. Scale: \< 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease), and \> 450 (severely active disease). A CDAI was calculated at each visit for participants ≥ 13 yrs old at M06-806 entry. Clinical response was defined as a decrease from M06-806 Baseline CDAI value of ≥ 70 pts. The M06-806 Baseline value was defined as the last non-missing value on or before the date of the 1st dose of study drug in M06-806.

Outcome measures

Outcome measures
Measure	Any Adalimumab n=64 Participants Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 264	24 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 8	56 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 12	51 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 24	52 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 48	48 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 60	48 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 72	45 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 108	47 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 120	40 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 144	41 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 168	34 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 192	33 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 216	28 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 36	53 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 0	55 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 4	56 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 240	28 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 288	18 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 312	15 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 336	9 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 360	7 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 384	1 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 84	47 Participants
Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time Week 96	45 Participants

SECONDARY outcome

Timeframe: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384

Population: Participants with corticosteroid use at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.

Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit.

Outcome measures

Outcome measures
Measure	Any Adalimumab n=37 Participants Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 0	23 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 4	23 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 8	23 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 12	20 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 24	21 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 36	19 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 48	19 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 60	24 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 72	17 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 84	19 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 96	20 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 108	18 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 120	19 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 144	17 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 168	16 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 192	15 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 216	13 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 240	13 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 264	11 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 288	9 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 312	5 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 336	2 Participants
Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time Week 360	1 Participants

SECONDARY outcome

Timeframe: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384

Population: Participants ≥ 13 years old with corticosteroid use at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.

The CDAI includes 8 variables encompassing subject-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. Participants kept track of daily symptoms on a diary card, and the scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: \< 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease), and \> 450 (severely active disease). A CDAI was calculated at each visit for subjects ≥ 13 years old at M06-806 entry. CDAI corticosteroid-free remission was defined as discontinued use at least 90 consecutive days prior to the respective visit and a CDAI \< 150 at that visit.

Outcome measures

Outcome measures
Measure	Any Adalimumab n=26 Participants Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 12	20 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 96	20 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 240	10 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 0	21 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 4	22 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 8	22 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 24	21 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 36	22 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 48	22 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 60	21 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 72	19 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 84	20 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 108	18 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 120	16 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 144	15 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 168	13 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 192	11 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 216	10 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 264	8 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 288	6 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 312	4 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 336	2 Participants
Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time Week 360	1 Participants

SECONDARY outcome

Timeframe: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384

Population: ITT Population: all participants who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.

Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The baseline value was defined as the last non-missing value on or before the date of the first dose of study drug in Study M06-806. Negative changes indicate reductions (improvement) in disease activity.

Outcome measures

Outcome measures
Measure	Any Adalimumab n=100 Participants Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 0	-29.95 units on a scale Standard Deviation 11.459
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 4	-30.15 units on a scale Standard Deviation 11.514
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 8	-30.7 units on a scale Standard Deviation 11.415
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 12	-29.19 units on a scale Standard Deviation 11.405
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 24	-29.84 units on a scale Standard Deviation 11.702
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 36	-30.89 units on a scale Standard Deviation 12.354
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 48	-30.73 units on a scale Standard Deviation 11.983
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 60	-32.78 units on a scale Standard Deviation 10.927
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 72	-31.15 units on a scale Standard Deviation 10.404
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 84	-32.94 units on a scale Standard Deviation 10.809
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 96	-31.14 units on a scale Standard Deviation 11.33
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 108	-33.54 units on a scale Standard Deviation 9.538
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 120	-33.36 units on a scale Standard Deviation 10.441
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 144	-34.38 units on a scale Standard Deviation 9.204
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 168	-32.57 units on a scale Standard Deviation 11.273
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 192	-33.00 units on a scale Standard Deviation 13.258
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 216	-31.95 units on a scale Standard Deviation 12.344
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 240	-34.18 units on a scale Standard Deviation 13.386
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 264	-35.00 units on a scale Standard Deviation 9.242
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 288	-35.95 units on a scale Standard Deviation 11.941
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 312	-33.19 units on a scale Standard Deviation 14.318
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 336	-35.23 units on a scale Standard Deviation 12.013
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 360	-38.75 units on a scale Standard Deviation 10.69
Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time Week 384	-46.25 units on a scale Standard Deviation 22.981

SECONDARY outcome

Timeframe: Week 0, 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384

Population: Participants ≥ 13 years old at Study M06-806 entry who received ≥ 1 dose of adalimumab in Study M06-807 and also had ≥ 1 non-missing efficacy measurement during the study.

The CDAI includes 8 variables: participant-reported (symptoms, general well-being) and objective (medication usage, laboratory variables, presence of abdominal mass or complications, and weight) variables. Participants kept track of daily symptoms on a diary card, and the scores were summed for the week. Each item in the CDAI is assigned a specific weight, and the items are totaled to produce the CDAI score. Higher CDAI scores indicate greater disease activity; 0 is the lower limit with no set upper limit. The scale for the score is as follows: \< 150 (remission), 150 - 219 (mildly active disease), 220 - 450 (moderately active disease) and \> 450 (severely active disease). A CDAI was calculated at each visit for those who were ≥ 13 years old at Study M06-806 entry. The baseline value was defined as the last non-missing value on or before the date of the first dose of study drug in Study M06-806. Negative changes indicate reductions (improvement) in disease activity.

Outcome measures

Outcome measures
Measure	Any Adalimumab n=64 Participants Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 384	-458.00 units on a scale
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 0	-160.8 units on a scale Standard Deviation 82.543
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 4	-159.9 units on a scale Standard Deviation 79.986
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 8	-164.45 units on a scale Standard Deviation 79.272
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 12	-151.34 units on a scale Standard Deviation 87.157
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 24	-161.51 units on a scale Standard Deviation 84.663
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 36	-173.55 units on a scale Standard Deviation 77.358
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 48	-162.08 units on a scale Standard Deviation 86.292
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 60	-168.27 units on a scale Standard Deviation 82.605
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 72	-165.4 units on a scale Standard Deviation 80.038
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 84	-172.68 units on a scale Standard Deviation 86.223
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 96	-168.3 units on a scale Standard Deviation 79.658
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 108	-171.63 units on a scale Standard Deviation 85.19
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 120	-179.14 units on a scale Standard Deviation 86.93
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 144	-181.53 units on a scale Standard Deviation 78.99
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 168	-175.05 units on a scale Standard Deviation 80.965
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 192	-172.42 units on a scale Standard Deviation 76.381
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 216	-173.13 units on a scale Standard Deviation 78.588
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 240	-184.46 units on a scale Standard Deviation 94.114
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 264	-186.42 units on a scale Standard Deviation 75.396
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 288	-197.11 units on a scale Standard Deviation 88.029
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 312	-199.00 units on a scale Standard Deviation 77.184
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 336	-240.33 units on a scale Standard Deviation 97.395
Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time Week 360	-224.86 units on a scale Standard Deviation 89.025

Adverse Events

Any Adalimumab

Serious events: 48 serious events

Other events: 98 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Any Adalimumab n=100 participants at risk Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Blood and lymphatic system disorders ANAEMIA	2.0% 2/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Blood and lymphatic system disorders LYMPHADENITIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Ear and labyrinth disorders VERTIGO	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders ABDOMINAL PAIN	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders COLITIS ULCERATIVE	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders CONSTIPATION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders CROHN'S DISEASE	25.0% 25/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders FAECAL VOLUME INCREASED	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders GASTRITIS	2.0% 2/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders GASTROINTESTINAL PAIN	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders ILEAL PERFORATION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders ILEAL STENOSIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders LARGE INTESTINAL STENOSIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders LARGE INTESTINE PERFORATION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders OESOPHAGITIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders PANCREATITIS ACUTE	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders SMALL INTESTINAL STENOSIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders STOMATITIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders FATIGUE	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders PYREXIA	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Hepatobiliary disorders HEPATITIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations ABDOMINAL ABSCESS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations ANAL ABSCESS	3.0% 3/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations CYSTITIS VIRAL	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations GASTROENTERITIS	2.0% 2/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations HERPES VIRUS INFECTION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations IMPETIGO	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PELVIC ABSCESS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PERIRECTAL ABSCESS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PERITONITIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PNEUMONIA	2.0% 2/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SALMONELLOSIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SINUSITIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations STAPHYLOCOCCAL ABSCESS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SUBCUTANEOUS ABSCESS	2.0% 2/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations TONSILLITIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations TOOTH ABSCESS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations VIRAL INFECTION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations YERSINIA INFECTION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications BONE CONTUSION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications CONCUSSION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications FACIAL BONES FRACTURE	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications RADIUS FRACTURE	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications ULNA FRACTURE	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications UPPER LIMB FRACTURE	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Investigations HEART RATE IRREGULAR	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders SYSTEMIC LUPUS ERYTHEMATOSUS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders DIZZINESS	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders SYNCOPE	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Psychiatric disorders SCHIZOAFFECTIVE DISORDER	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Psychiatric disorders SOMATIC SYMPTOM DISORDER	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Psychiatric disorders SUICIDAL IDEATION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders PELVIC FLUID COLLECTION	1.0% 1/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.

Other adverse events

Other adverse events
Measure	Any Adalimumab n=100 participants at risk Adalimumab was administered via subcutaneous injection. Dosage was based on body weight and clinical status, and ranged from 10, 20, or 40 mg every other week to 20 or 40 mg every week.
Blood and lymphatic system disorders ANAEMIA	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Blood and lymphatic system disorders LEUKOPENIA	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Blood and lymphatic system disorders LYMPHADENOPATHY	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Cardiac disorders PALPITATIONS	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Ear and labyrinth disorders EAR PAIN	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders ABDOMINAL PAIN	24.0% 24/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	15.0% 15/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders ANAL FISSURE	9.0% 9/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders CONSTIPATION	15.0% 15/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders CROHN'S DISEASE	24.0% 24/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders DIARRHOEA	26.0% 26/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders DYSPEPSIA	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders HAEMATOCHEZIA	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders MALPOSITIONED TEETH	6.0% 6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders NAUSEA	19.0% 19/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders RECTAL HAEMORRHAGE	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders TOOTHACHE	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Gastrointestinal disorders VOMITING	22.0% 22/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders FATIGUE	18.0% 18/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders INJECTION SITE PAIN	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders INJECTION SITE REACTION	16.0% 16/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders PAIN	6.0% 6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
General disorders PYREXIA	20.0% 20/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Immune system disorders HYPERSENSITIVITY	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Immune system disorders SEASONAL ALLERGY	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations BRONCHITIS	11.0% 11/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations CONJUNCTIVITIS	9.0% 9/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations EAR INFECTION	10.0% 10/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations EYE INFECTION	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations GASTROENTERITIS	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations GASTROENTERITIS VIRAL	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations HERPES ZOSTER	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations IMPETIGO	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations INFLUENZA	15.0% 15/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations ORAL HERPES	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations OTITIS MEDIA	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PHARYNGITIS	20.0% 20/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PHARYNGITIS STREPTOCOCCAL	14.0% 14/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations PNEUMONIA	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations RESPIRATORY TRACT INFECTION VIRAL	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations RHINITIS	10.0% 10/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations SINUSITIS	17.0% 17/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations STAPHYLOCOCCAL INFECTION	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations TONSILLITIS	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	31.0% 31/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations URINARY TRACT INFECTION	14.0% 14/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations VIRAL INFECTION	18.0% 18/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	39.0% 39/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications CONTUSION	6.0% 6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Injury, poisoning and procedural complications PROCEDURAL PAIN	9.0% 9/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Investigations ALANINE AMINOTRANSFERASE INCREASED	6.0% 6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Investigations ANTINUCLEAR ANTIBODY POSITIVE	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Investigations C-REACTIVE PROTEIN INCREASED	15.0% 15/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Investigations RED BLOOD CELL SEDIMENTATION RATE INCREASED	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Metabolism and nutrition disorders DECREASED APPETITE	6.0% 6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders ARTHRALGIA	21.0% 21/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders BACK PAIN	14.0% 14/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders JOINT SWELLING	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders MYALGIA	9.0% 9/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	9.0% 9/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN PAPILLOMA	13.0% 13/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders DIZZINESS	6.0% 6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders HEADACHE	37.0% 37/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Nervous system disorders MIGRAINE	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Psychiatric disorders DEPRESSION	6.0% 6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Psychiatric disorders INSOMNIA	6.0% 6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Reproductive system and breast disorders DYSMENORRHOEA	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders COUGH	20.0% 20/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	6.0% 6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	12.0% 12/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	27.0% 27/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Respiratory, thoracic and mediastinal disorders SINUS CONGESTION	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders ACNE	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders ALOPECIA	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders DRY SKIN	7.0% 7/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders ECZEMA	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders ERYTHEMA	6.0% 6/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders PSORIASIS	5.0% 5/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders RASH	15.0% 15/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.
Skin and subcutaneous tissue disorders URTICARIA	8.0% 8/100 • Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration in Study M06-806 until 70 days after the last dose of study drug in Study M06-807 (up to 470 weeks). TEAEs and TESAEs are defined as any adverse event (AE) or serious adverse event (SAE) with an onset date that is after the first dose of study drug until 70 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant.

Additional Information

Global Medical Services

AbbVie (prior sponsor, Abbott)

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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Restriction type: OTHER