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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-004157-28 | EudraCT Number |
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To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab 40 mg EOW/EW | Experimental | Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | adalimumab prefilled syringes administered as subcutaneous injection EW or EOW |
|
| Measure | Description | Time Frame |
|---|---|---|
| Partial Mayo Score: Change From Baseline Over Time | The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| Mayo Score: Change From Baseline Over Time | The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Remission Per Partial Mayo Score Over Time | The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). Remission was defined as Partial Mayo score ≤ 2 with no subscore > 1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25155227 | Background | Colombel JF, Sandborn WJ, Ghosh S, Wolf DC, Panaccione R, Feagan B, Reinisch W, Robinson AM, Lazar A, Kron M, Huang B, Skup M, Thakkar RB. Four-year maintenance treatment with adalimumab in patients with moderately to severely active ulcerative colitis: Data from ULTRA 1, 2, and 3. Am J Gastroenterol. 2014 Nov;109(11):1771-80. doi: 10.1038/ajg.2014.242. Epub 2014 Aug 26. | |
| 29380251 |
| Label | URL |
|---|---|
| Related Info. | View source |
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A total of 592 subjects were randomized and received at least 1 dose of study drug (safety population); 7 subjects enrolled at 3 noncompliant sites were excluded from the analyses (Intent-to-treat 1 [ITT-1] population; N=585).
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab 40 mg EOW/EW | Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT-1: All subjects who received ≥1 dose of study drug excluding 7 subjects at noncompliant sites.
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab 40 mg EOW/EW | Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Partial Mayo Score: Change From Baseline Over Time | The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks).
TEAEs and TESAEs are defined as any adverse event or serious adverse event with onset or worsening from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs 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 | Adalimumab 40 mg EOW/EW | Open-label adalimumab 40 mg every other week (EOW) or every week (EW). Participants who entered from an open-label cohort continued their previous dosing regimen of adalimumab EOW or EW; participants who entered from a double-blind cohort received adalimumab EOW. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
Efficacy data after Week 292 should be interpreted with caution because less than 10% of subjects were under observation beyond Week 292.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| 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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| Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| Mayo Endoscopy Subscore: Change From Baseline Over Time | The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | The Mayo Rectal Bleeding subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Rectal Bleeding subscore indicates improvement. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | The Mayo Physician's Global Assessment of Disease Severity subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Physician's Global Assessment of Disease Severity subscore indicates improvement. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| Mayo Stool Frequency Subscore: Change From Baseline Over Time | The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | The IBDQ is a 32-item questionnaire that assesses how the subject felt during the 2 weeks before the measurement time point. Questions are related to symptoms the subject might have had as a result of UC, how the subject felt in general, how the subject's mood was, and social and work problems the subject might have that resulted from UC. An increase in IBDQ score indicates less impact of UC on the subject's life. The responses to each question range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| WPAI:GH Impairment While Working: Change From Baseline Over Time | The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| WPAI:GH Overall Work Impairment: Change From Baseline Over Time | The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| WPAI:GH Activity Impairment: Change From Baseline Over Time | The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
| Colectomy Rate | The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy. | 5 years |
| Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations | The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to ulcerative colitis since the last visit. The cumulative number of unscheduled utilizations over the course of the study is presented. | 5 years |
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section. | From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks) |
| Hematology: Mean Change From Baseline to Final Values in Hemoglobin | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Baseline (Week 0), final value (up to 5 years) |
| Hematology: Mean Change From Baseline to Final Values in Hematocrit | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Baseline (Week 0), final value (up to 5 years) |
| Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Baseline (Week 0), final value (up to 5 years) |
| Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Baseline (Week 0), final value (up to 5 years) |
| Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Baseline (Week 0), final value (up to 5 years) |
| Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Baseline (Week 0), final value (up to 5 years) |
| Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Baseline (Week 0), final value (up to 5 years) |
| Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Baseline (Week 0), final value (up to 5 years) |
| Derived |
| Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6. |
| Protocol Violation |
|
| Lack of Efficacy |
|
| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Mayo Score: Change From Baseline Over Time | The Mayo score ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding, endoscopy, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | Percentage of Participants With Remission Per Partial Mayo Score Over Time | The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). Remission was defined as Partial Mayo score ≤ 2 with no subscore > 1. | Participants in ITT-1 population with evaluable data at given timepoint. | Posted | Number | percentage of participants | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | Mayo Endoscopy Subscore: Change From Baseline Over Time | The Mayo Endoscopy subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Endoscopy subscore indicates improvement. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | Mayo Rectal Bleeding Subscore: Change From Baseline Over Time | The Mayo Rectal Bleeding subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Rectal Bleeding subscore indicates improvement. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | Mayo Physician's Global Assessment of Disease Severity Subscore: Change From Baseline Over Time | The Mayo Physician's Global Assessment of Disease Severity subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Physician's Global Assessment of Disease Severity subscore indicates improvement. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | Mayo Stool Frequency Subscore: Change From Baseline Over Time | The Mayo Stool Frequency subscore ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo Stool Frequency subscore indicates improvement. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | Inflammatory Bowel Disease Questionnaire (IBDQ): Change From Baseline Over Time | The IBDQ is a 32-item questionnaire that assesses how the subject felt during the 2 weeks before the measurement time point. Questions are related to symptoms the subject might have had as a result of UC, how the subject felt in general, how the subject's mood was, and social and work problems the subject might have that resulted from UC. An increase in IBDQ score indicates less impact of UC on the subject's life. The responses to each question range from 1 (significant impairment) to 7 (no impairment), with the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | 36-Item Short Form Health Survey Version 2 (SF-36) Mental Component Score: Change From Baseline Over Time | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | 36-Item Short Form Health Survey Version 2 (SF-36) Physical Component Score: Change From Baseline Over Time | The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 (poorest health) to 100 (best health) scale with higher scores indicating better health status or functioning. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | Work Productivity and Activity Impairment: General Health Version 2.0 (WPAI:GH) Work Time Missed Because of Ulcerative Colitis: Change From Baseline Over Time | The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | percent of work time missed | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | WPAI:GH Impairment While Working: Change From Baseline Over Time | The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | percent of work time impaired | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | WPAI:GH Overall Work Impairment: Change From Baseline Over Time | The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | percent of overall work impairment | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | WPAI:GH Activity Impairment: Change From Baseline Over Time | The WPAI:GH questionnaire was used to assess work and activity impairment due to symptoms of ulcerative colitis in the last 7 days. The self-administered questionnaire measures the effect of the subject's health problems on work and daily activities in the previous week, specifically, the number of hours missed from work due to health problems, how much the subject's health problems affected work productivity, and how much the subject's health problems affected regular activities. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | percent activity impaired | Baseline (Week 0), Weeks 48, 96, 144, 192, 240, 292, 340, 388 |
|
|
|
| Secondary | Colectomy Rate | The colectomy rates were estimated using Kaplan-Meier methodology based on the time to first colectomy. | ITT-1 population | Posted | Number | percentage of participants | 5 years |
|
|
|
| Secondary | Health Care Resource Utilization (HCRU): Cumulative Number of Unscheduled Utilizations | The HCRU assesses the frequency of unscheduled outpatient visits, emergency room visits, or hospitalizations due to ulcerative colitis since the last visit. The cumulative number of unscheduled utilizations over the course of the study is presented. | ITT-1 population | Posted | Number | cumulative number of utilizations | 5 years |
|
|
|
| Secondary | Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section. | Safety analysis set: all participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | From first dose of study drug until 70 days after the last dose of study drug (up to 398 weeks) |
|
|
|
| Secondary | Hematology: Mean Change From Baseline to Final Values in Hemoglobin | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Participants in the safety analysis set with both Baseline and visit values. | Posted | Mean | Standard Deviation | g/L | Baseline (Week 0), final value (up to 5 years) |
|
|
|
| Secondary | Hematology: Mean Change From Baseline to Final Values in Hematocrit | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Participants in the safety analysis set with both Baseline and visit values. | Posted | Mean | Standard Deviation | Percentage of red blood cells | Baseline (Week 0), final value (up to 5 years) |
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| Secondary | Hematology: Mean Change From Baseline to Final Values in Red Blood Cell Count, Platelet Count, White Blood Cell Count, Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Participants in the safety analysis set with both Baseline and visit values. | Posted | Mean | Standard Deviation | cells * 10^9/L | Baseline (Week 0), final value (up to 5 years) |
|
|
|
| Secondary | Clinical Chemistry: Mean Change From Baseline to Final Values in Alanine Aminotransferase, Aspartate Aminotransferase, and Alkaline Phosphatase | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Participants in the safety analysis set with both Baseline and visit values. | Posted | Mean | Standard Deviation | U/L | Baseline (Week 0), final value (up to 5 years) |
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| Secondary | Clinical Chemistry: Mean Change From Baseline to Final Values in Total Bilirubin, Creatinine, and Uric Acid | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Participants in ITT-1 population with both Baseline and visit values. | Posted | Mean | Standard Deviation | μmol/L | Baseline (Week 0), final value (up to 5 years) |
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| Secondary | Clinical Chemistry: Mean Change From Baseline to Final Values in Blood Urea Nitrogen, Inorganic Phosphate, Calcium, Sodium, Potassium, Glucose, Cholesterol, and Triglycerides | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Participants in the safety analysis set with both Baseline and visit values. | Posted | Mean | Standard Deviation | mmol/L | Baseline (Week 0), final value (up to 5 years) |
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|
|
| Secondary | Clinical Chemistry: Mean Change From Baseline to Final Values in Albumin and Total Protein | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Participants in the safety analysis set with both Baseline and visit values. | Posted | Mean | Standard Deviation | g/L | Baseline (Week 0), final value (up to 5 years) |
|
|
|
| Secondary | Clinical Chemistry: Mean Change From Baseline to Final Values in High-sensitivity C-reactive Protein | Blood samples for laboratory tests were performed at each study visit after questionnaires and vital sign determinations. | Participants in the safety analysis set with both Baseline and visit values. | Posted | Mean | Standard Deviation | mg/L | Baseline (Week 0), final value (up to 5 years) |
|
|
|
| 158 |
| 592 |
| 391 |
| 592 |
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
|
| LYMPHADENOPATHY MEDIASTINAL | Blood and lymphatic system disorders | MedDRA 19.1 | Systematic Assessment |
|
| AORTIC VALVE STENOSIS | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| CARDIOGENIC SHOCK | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| LEFT VENTRICULAR DYSFUNCTION | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| RIGHT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| TACHYCARDIA | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| HYPERTROPHIC CARDIOMYOPATHY | Congenital, familial and genetic disorders | MedDRA 19.1 | Systematic Assessment |
|
| ADRENAL HAEMORRHAGE | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
|
| GOITRE | Endocrine disorders | MedDRA 19.1 | Systematic Assessment |
|
| OPTIC ISCHAEMIC NEUROPATHY | Eye disorders | MedDRA 19.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| ANAL FISTULA | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| COLITIS | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| COLON DYSPLASIA | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| GASTROINTESTINAL DYSPLASIA | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| ILEUS | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| INGUINAL HERNIA | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| LARGE INTESTINAL STENOSIS | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| LARGE INTESTINE PERFORATION | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| PNEUMOPERITONEUM | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| PSEUDOPOLYPOSIS | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| RECTAL PERFORATION | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| RECTAL POLYP | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| DRUG INTOLERANCE | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| DYSPLASIA | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| MULTIMORBIDITY | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| NON-CARDIAC CHEST PAIN | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| POLYP | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| SYSTEMIC INFLAMMATORY RESPONSE SYNDROME | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| PORTAL HYPERTENSION | Hepatobiliary disorders | MedDRA 19.1 | Systematic Assessment |
|
| ABDOMINAL ABSCESS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| ABSCESS OF SALIVARY GLAND | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| ANAL ABSCESS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| APPENDICITIS PERFORATED | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| CHRONIC SINUSITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| CLOSTRIDIUM DIFFICILE INFECTION | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| COLONIC ABSCESS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| DIARRHOEA INFECTIOUS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| DIVERTICULITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| HERPES ZOSTER MENINGITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| INFECTION | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| INJECTION SITE ABSCESS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| INJECTION SITE CELLULITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| LUNG ABSCESS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| ORCHITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| PERITONITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| PULMONARY TUBERCULOSIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| STAPHYLOCOCCAL INFECTION | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| SUBCUTANEOUS ABSCESS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| ANIMAL BITE | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| HEAD INJURY | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| HIP FRACTURE | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| JOINT INJURY | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| MENISCUS INJURY | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| TENDON RUPTURE | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| TIBIA FRACTURE | Injury, poisoning and procedural complications | MedDRA 19.1 | Systematic Assessment |
|
| FALSE POSITIVE TUBERCULOSIS TEST | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 19.1 | Systematic Assessment |
|
| HYPOKALAEMIA | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 19.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| CERVICAL SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| DUPUYTREN'S CONTRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| LUPUS-LIKE SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| OSTEOPOROSIS | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| OSTEOPOROTIC FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| SYMPATHETIC POSTERIOR CERVICAL SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| BLADDER CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| BLADDER TRANSITIONAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| CERVIX CARCINOMA STAGE 0 | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| ENDOMETRIAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| GALLBLADDER ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| PANCREATIC NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| SQUAMOUS CELL CARCINOMA OF SKIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| AUTONOMIC NERVOUS SYSTEM IMBALANCE | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| CAROTID ARTERY STENOSIS | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| CARPAL TUNNEL SYNDROME | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| DEMYELINATION | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| GENERALISED TONIC-CLONIC SEIZURE | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| ISCHAEMIC STROKE | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| MULTIPLE SCLEROSIS | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| NERVE COMPRESSION | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 19.1 | Systematic Assessment |
|
| BIPOLAR I DISORDER | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| PSYCHOTIC BEHAVIOUR | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 19.1 | Systematic Assessment |
|
| DYSURIA | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| URETEROLITHIASIS | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| URINARY INCONTINENCE | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| MENORRHAGIA | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| PROSTATISM | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| PROSTATITIS | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| UTERINE CYST | Reproductive system and breast disorders | MedDRA 19.1 | Systematic Assessment |
|
| ALLERGIC RESPIRATORY SYMPTOM | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| BRONCHIECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| NASAL OBSTRUCTION | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| NASAL SEPTUM DEVIATION | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| SLEEP APNOEA SYNDROME | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| ERYTHEMA MULTIFORME | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| ERYTHEMA NODOSUM | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| HENOCH-SCHONLEIN PURPURA | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| ABORTION INDUCED | Surgical and medical procedures | MedDRA 19.1 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| HAEMORRHAGIC INFARCTION | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 19.1 | Systematic Assessment |
|
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.
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Week 96 |
|
|
| Week 144 |
|
|
| Week 192 |
|
|
| Week 240 |
|
|
| Week 292 |
|
|
| Week 340 |
|
|
| Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
|
| Change from Baseline to Week 96 |
|
|
| Change from Baseline to Week 144 |
|
|
| Change from Baseline to Week 192 |
|
|
| Change from Baseline to Week 240 |
|
|
| Change from Baseline to Week 292 |
|
|
| Change from Baseline to Week 340 |
|
|
| Change from Baseline to Week 388 |
|
|
| Title | Measurements |
|---|---|
|
| Days in Hospital |
|
|
| White blood cell count |
|
|
| Neutrophils |
|
|
| Lymphocytes |
|
|
| Monocytes |
|
|
| Eosinophils |
|
|
| Basophils |
|
|
|
| Alkaline phosphatase |
|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Sodium |
|
| Potassium |
|
| Glucose |
|
| Cholesterol |
|
| Triglycerides |
|