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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-006494-90 | EudraCT Number |
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This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody adalimumab as an effective therapy for maintaining clinical response in pediatric participants with Crohn's disease (CD) and to gather long-term safety and tolerability data in this population. Participants were allowed to enroll in the study if they participated in and successfully completed Study M06-806 (NCT00409682) through Week 52.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Any adalimumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | Participants who enrolled into the study from blinded therapy in Study M06-806 received open-label (OL) therapy at a dose dependent on their body weight. Participants weighing ≥ 40 kg received 40 mg of adalimumab every other week (eow), and those who weighed < 40 kg received 20 mg of adalimumab eow. Starting at Week 8, participants who had a disease flare may have been switched to every week (ew) treatment at the same dose of adalimumab received while on eow treatment. Participants who enrolled from OL therapy in Study M06-806 continued to receive the same dose they were receiving (i.e., 40 mg ew or 20 mg ew) at the Week 52 visit of Study M06-806. Adalimumab dose could have been decreased to the next lower treatment level for those with body weight changes. Participants who responded to treatment may have also had their dosage frequency decreased from ew to eow dosing, as well as a decrease in dosage. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time | 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. Clinical remission was defined as PCDAI ≤ 10. | 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 |
| Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time | 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. |
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Inclusion Criteria:
Participant must have successfully enrolled in and completed Study M06-806 through Week 52.
Participant must have been a responder at any time point during the M06-806 study (defined as having achieved at least a 15-point reduction in the Pediatric Crohn's Disease Activity Index (PCDAI) from Baseline).
If female, participants who were sexually active and of child-bearing potential were to be practicing an approved method of birth control throughout the study and for 150 days after study drug administration. Examples of approved methods of birth control included the following:
Participant of legal age, parent or legal guardian, as required, voluntarily signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form, after the nature of the study was explained and the participant of legal age, participant's parent, or legal guardian, as required, had the opportunity to ask questions. Participants were to be included in all discussions, and if required, their signature on an assent form was to be obtained.
Parent or legal guardian of participant who was not of legal age, as required, must have been willing to actively supervise storage and administration of study drug and to ensure that the time of each dose was accurately recorded in the participant's diary.
Participants of legal age, must have been willing to actively store, administer, and accurately record study drug administration in the participant diary.
Participant was judged to be in acceptable medical condition, as determined by the Principal Investigator based upon results of clinical and laboratory evaluations done throughout the preceding Crohn's disease study M06-806.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Lazar | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28129288 | Result | Faubion WA, Dubinsky M, Ruemmele FM, Escher J, Rosh J, Hyams JS, Eichner S, Li Y, Reilly N, Thakkar RB, Robinson AM, Lazar A. Long-term Efficacy and Safety of Adalimumab in Pediatric Patients with Crohn's Disease. Inflamm Bowel Dis. 2017 Mar;23(3):453-460. doi: 10.1097/MIB.0000000000001021. | |
| 30054164 | Derived |
| Label | URL |
|---|---|
| Related Info | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at Study M06-806 Baseline |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Achieved Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission Over Time | 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. Clinical remission was defined as PCDAI ≤ 10. | 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. | Posted | Count of Participants | Participants | No | 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 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 26, 2015 | Feb 28, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2017 | Feb 28, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| 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 |
| Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time | 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. | 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 |
| Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time | 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. | 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 |
| Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time | 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. | 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 |
| Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time | 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. | 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 |
| Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time | 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. | 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 |
| Horneff G, Seyger MMB, Arikan D, Kalabic J, Anderson JK, Lazar A, Williams DA, Wang C, Tarzynski-Potempa R, Hyams JS. Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's Disease. J Pediatr. 2018 Oct;201:166-175.e3. doi: 10.1016/j.jpeds.2018.05.042. Epub 2018 Jul 25. |
| 29939254 | Derived | Ruemmele FM, Rosh J, Faubion WA, Dubinsky MC, Turner D, Lazar A, Eichner S, Maa JF, Alperovich G, Robinson AM, Hyams JS. Efficacy of Adalimumab for Treatment of Perianal Fistula in Children with Moderately to Severely Active Crohn's Disease: Results from IMAgINE 1 and IMAgINE 2. J Crohns Colitis. 2018 Nov 9;12(10):1249-1254. doi: 10.1093/ecco-jcc/jjy087. |
| Lost to Follow-up |
|
| Missing reason |
|
| Other, not specified |
|
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Body weight at Study M06-806 Baseline | Count of Participants | Participants | No |
|
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.
|
|
| Primary | Number of Participants With Clinical Response as Defined by Pediatric Crohn's Disease Activity Index (PCDAI) Score Over Time | 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. | 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. | Posted | Count of Participants | Participants | No | 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 |
|
|
|
| Secondary | Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Remission Over Time | 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. | 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. | Posted | Count of Participants | Participants | No | 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 |
|
|
|
| Secondary | Number of Participants Who Were in Crohn's Disease Activity Index (CDAI) Clinical Response Over Time | 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. | 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. | Posted | Count of Participants | Participants | No | 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 |
|
|
|
| Secondary | Number of Participants in Steroid-free Pediatric Crohn's Disease Activity Index (PCDAI) Remission Over Time | 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. | 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. | Posted | Count of Participants | Participants | No | 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 |
|
|
|
| Secondary | Number of Participants in Steroid-free Crohn's Disease Activity Index (CDAI) Remission Over Time | 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. | 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. | Posted | Count of Participants | Participants | No | 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 |
|
|
|
| Secondary | Mean Change From Baseline in Pediatric Crohn's Disease Activity Index (PCDAI) Over Time | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
| Secondary | Mean Change From Baseline in Crohn's Disease Activity Index (CDAI) Over Time | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 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 |
|
|
|
| 0 |
| 100 |
| 48 |
| 100 |
| 98 |
| 100 |
| LYMPHADENITIS | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| FAECAL VOLUME INCREASED | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| GASTRITIS | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| GASTROINTESTINAL PAIN | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| ILEAL PERFORATION | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| ILEAL STENOSIS | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| LARGE INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| OESOPHAGITIS | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| SMALL INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| HEPATITIS | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| CYSTITIS VIRAL | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| HERPES VIRUS INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| IMPETIGO | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| PELVIC ABSCESS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| PERIRECTAL ABSCESS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| PERITONITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| SALMONELLOSIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| STAPHYLOCOCCAL ABSCESS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| TONSILLITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| TOOTH ABSCESS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| YERSINIA INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| BONE CONTUSION | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| CONCUSSION | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| ULNA FRACTURE | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| HEART RATE IRREGULAR | Investigations | MedDRA 20.0 | Systematic Assessment |
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| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| SYSTEMIC LUPUS ERYTHEMATOSUS | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| SCHIZOAFFECTIVE DISORDER | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| SOMATIC SYMPTOM DISORDER | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| PELVIC FLUID COLLECTION | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| PALPITATIONS | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
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| EAR PAIN | Ear and labyrinth disorders | MedDRA 20.0 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| ANAL FISSURE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| DYSPEPSIA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| MALPOSITIONED TEETH | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 20.0 | Systematic Assessment |
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| INJECTION SITE PAIN | General disorders | MedDRA 20.0 | Systematic Assessment |
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| INJECTION SITE REACTION | General disorders | MedDRA 20.0 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 20.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 20.0 | Systematic Assessment |
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| HYPERSENSITIVITY | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
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| SEASONAL ALLERGY | Immune system disorders | MedDRA 20.0 | Systematic Assessment |
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| BRONCHITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| CONJUNCTIVITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| EAR INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| EYE INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| HERPES ZOSTER | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| IMPETIGO | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| OTITIS MEDIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| PHARYNGITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| RESPIRATORY TRACT INFECTION VIRAL | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| RHINITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| TONSILLITIS | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| CONTUSION | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| PROCEDURAL PAIN | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
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| ANTINUCLEAR ANTIBODY POSITIVE | Investigations | MedDRA 20.0 | Systematic Assessment |
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| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
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| RED BLOOD CELL SEDIMENTATION RATE INCREASED | Investigations | MedDRA 20.0 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| SKIN PAPILLOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| MIGRAINE | Nervous system disorders | MedDRA 20.0 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 20.0 | Systematic Assessment |
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| DYSMENORRHOEA | Reproductive system and breast disorders | MedDRA 20.0 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| SINUS CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
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| ACNE | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| ALOPECIA | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 20.0 | Systematic Assessment |
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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.
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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