Trial Comparing Infliximab and Infliximab and Azathioprine in the Treatment of Patients With Crohn's Disease na�ve to Both Immunomodulators and Biologic Therapy (Study of Biologic and Immunomodulator Naive Patients in Chrohn's Disease: SONIC
Official Title
Multicenter, Randomized, Double-Blind, Active Controlled Trial Comparing REMICADE� (Infliximab) and REMICADE Plus Azathioprine to Azathioprine in the Treatment of Patients With Crohn's Disease Naive to Both Immunomodulators and Biologic Therapy
Acronym
Not provided
Organization
Centocor Ortho Biotech Services, L.L.C.INDUSTRY
Status Module
Record Verification Date
Dec 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 2005
Primary Completion Date
Apr 2008Actual
Completion Date
Dec 2009Actual
First Submitted Date
Oct 19, 2004
First Submission Date that Met QC Criteria
Oct 19, 2004
First Posted Date
Oct 20, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 30, 2009
Results First Submitted that Met QC Criteria
May 4, 2009
Results First Posted Date
Jun 23, 2009Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 15, 2016
Last Update Posted Date
Feb 9, 2017Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Centocor Ortho Biotech Services, L.L.C.INDUSTRY
Collaborators
Name
Class
Schering-Plough
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to assess the safety and effectiveness of three different treatments for patients with Crohns disease who have not responded to previous treatment with a group of drugs commonly used to treat Crohn's Disease (5-ASA) and corticosteroids. Patients will receive either infliximab (a drug used to treat autoimmune diseases) or azathioprine (an immunosuppressant or drug used to suppress the immune system) or a combination of both for up to 34 weeks. This research study will involve approximately 500 patients. The main study involves up to 34 weeks (approximately 8 months). A study extension of an additional 20 weeks (approximately 5 months) is optional for patients who successfully complete the main study. A country-specific study extension of open label infliximab treatment for an additional 1 year is optional for patients who successfully complete the main study extension.
Detailed Description
Crohns disease is characterized by inflammation (the changes that happen when tissues in the body are injured) and ulceration (open sores) of the intestines. Crohns disease is treated with medications that decrease inflammation, and reduce diarrhea, abdominal pain and other symptoms of Crohns disease. In addition, Crohns disease can be treated with medications that suppress the immune system (the body system involved in inflammation and infections) or with surgery. This study will investigate the effectiveness of infliximab and azathioprine in the treatment of patients with moderate-to-severe Crohns disease. Infliximab is currently approved by the FDA for the treatment of both Crohns disease and rheumatoid arthritis. Azathioprine, which is an investigational drug, has not been approved by the FDA for the treatment of Crohns disease, but it is a well-established therapy that has been used for many years to treat Crohns disease. This study seeks to determine whether infliximab, azathioprine, or the combination of both drugs would be the most appropriate treatment for Crohns disease patients who have not responded well to certain drugs called 5-ASA drugs (e.g. Asacol, Pentasa, sulfasalazine) and/or require frequent treatment with corticosteroids. This research study will involve approximately 500 patients. Patients may participate in the main study for up to 34 weeks (approximately 8 months). During the main study, patients will be asked to visit the study center for 10 visits. If patients enroll into the extension of the study, the total time for participation may be up to 54 weeks (approximately 13 months). Patients enrolled in the Study Extension will be asked to visit the study center for an additional 5 visits. A country-specific (EU and Israel only), prospective, multi-center, open-label extension of the study will further evaluate the long-term safety and efficacy of scheduled maintenance therapy with infliximab in patients with Crohns Disease. Patients who have completed treatment through Week 50 in the SONIC main study and who, in the opinion of the investigator, would benefit from infliximab treatment may enter the open-label extension. Patients will be randomly assigned to one of three treatment groups (either infliximab plus placebo capsules, infliximab plus azathioprine, or azathioprine plus placebo infusions - there is no possibility of being assigned to placebo only in this trial - patients will receive one or both of these medications) at the beginning of the study. Oral medication will be taken daily. There are 5 infusion (which will be either infliximab or placebo) visits during the main study.
Conditions Module
Conditions
Crohn Disease
Keywords
Crohn's Disease
infliximab
azathioprine
Remicade
SONIC
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
508Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
003
Experimental
infliximab (IFX) infusion; azathioprine (AZA) caps AZA daily 2.5 mg/kg/day and IFX infusions 5 mg/kg at weeks 0, 2, 6, 14, and 22
infliximab infusion; AZA placebo caps Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules
Biological: infliximab infusion; AZA placebo caps
Interventions
Name
Type
Description
Arm Group Labels
Other Names
infliximab infusion; AZA placebo caps
Biological
Infliximab 5 mg/kg at weeks 0, 2, 6, 14, and 22 and placebo AZA capsules
002
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Corticosteriod-free Clinical Remission
Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (>=) 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).
Week 26
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Mucosal Healing
Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.
Week 26
Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Crohns Disease for at least 6 weeks
Moderate to severe disease activity (CDAI >= 220 and <=450)
No history of azathioprine, 6-MP (6 Mercaptopurine), or biologic treatments
Are either: Corticosteriod-dependent, OR considered for a 2nd (or greater) course of corticosteriod, OR 5-ASA failures, Or Budesonide failures
Exclusion Criteria:
History of abdominal surgery within the last 6 months
Have an ostomy or stoma [An operation to create an opening from an area inside the body to the outside]
Are pregnant, nursing, or planning pregnancy (both men and women)
Serious simultaneous illness that could interfere with study participation
Use of any investigational drug within 30 days
Have a concomitant diagnosis or any history of congestive heart failure
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
AZA daily 2.5 mg/kg/day and placebo IFX infusions at weeks 0, 2, 6, 14, and 22
001
Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) < 150 who have not received any dose of systemic corticosteroids (prednisone or equivalent) for >= 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).
Week 50
Percentage of Participants With Clinical Remission (Main Study)
Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)
Weeks 2, 6, 10, 18 and 26
Percentage of Participants With Clinical Remission (Study Extension)
Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)
Weeks 34, 42 and 50
Percentage of Participants With Clinical Response Over Time (Main Study)
Clinical response, defined as a >=100-point decrease in CDAI from Baseline.
Weeks 2, 6, 10, 18, 26
Percentage of Participants With Clinical Response Over Time (Study Extension)
Clinical response, defined as a >=100-point decrease in CDAI from Baseline.
Weeks 34, 42, 50
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study)
Quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32- item questionnaire and the total IBDQ score can range from 32 (very poor) to 224 (perfect).
Baseline and Weeks 2, 6, 10, 18, 26
Average Corticosteroid Use
Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)
Dulai PS, Wong ECL, Reinisch W, Narula N. Clinical Decision Support Tool for Infliximab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):e1192-e1195. doi: 10.1016/j.cgh.2021.06.037. Epub 2021 Jun 30.
Colombel JF, Reinisch W, Mantzaris GJ, Kornbluth A, Rutgeerts P, Tang KL, Oortwijn A, Bevelander GS, Cornillie FJ, Sandborn WJ. Randomised clinical trial: deep remission in biologic and immunomodulator naive patients with Crohn's disease - a SONIC post hoc analysis. Aliment Pharmacol Ther. 2015 Apr;41(8):734-46. doi: 10.1111/apt.13139. Epub 2015 Mar 1.
Ferrante M, Colombel JF, Sandborn WJ, Reinisch W, Mantzaris GJ, Kornbluth A, Rachmilewitz D, Lichtiger S, D'Haens GR, van der Woude CJ, Danese S, Diamond RH, Oortwijn AF, Tang KL, Miller M, Cornillie F, Rutgeerts PJ; International Organization for the Study of Inflammatory Bowel Diseases. Validation of endoscopic activity scores in patients with Crohn's disease based on a post hoc analysis of data from SONIC. Gastroenterology. 2013 Nov;145(5):978-986.e5. doi: 10.1053/j.gastro.2013.08.010. Epub 2013 Aug 14.
FG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
FG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
FG003
Azathioprine + Placebo/Infliximab
Participants received daily AZA oral capsules 2.5mg/kg/day and Placebo infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (EU and Israel) open-Label Extension.
FG004
Infliximab + Placebo/Infliximab
Participants received Placebo oral capsules daily and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
FG005
Infliximab + Azathioprine/Infliximab
Participants received daily AZA oral capsules 2.5mg/kg/day and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
FG000170 subjects
FG001169 subjects
FG002169 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00086 subjects
FG001111 subjects
FG002121 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00084 subjects
FG00158 subjects
FG00248 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Eligibility criteria not met
FG0003 subjects
FG0018 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0005 subjects
FG0015 subjects
FG0022 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG00018 subjects
FG0019 subjects
FG0027 subjects
FG0030 subjects
FG004
Adverse Event
FG00038 subjects
FG00120 subjects
FG00228 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG00019 subjects
FG00116 subjects
FG0029 subjects
FG0030 subjects
FG004
Study Extension: Week 30 Through Week 50
Type
Comment
Milestone Data
STARTED
FG00075 subjects
FG00197 subjects
FG002108 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00067 subjects
FG00185 subjects
FG00290 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0008 subjects
FG00112 subjects
FG00218 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0024 subjects
FG003
OLE: Open-Label Extension
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0038 subjects
FG00418 subjects
FG00517 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0037 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Azathioprine + Placebo
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
BG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
BG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000170
BG001169
BG002169
BG003508
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00036.3± 12.92
BG00136.6± 13
BG00235.9± 11.97
BG003
Gender
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00080
BG00185
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
AUSTRIA
Title
Measurements
BG0008
BG0019
BG002
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
Percentage of Participants With Corticosteriod-free Clinical Remission
Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) less than (<) 150 in participants who have not received any dose of systemic corticosteroids (prednisone or equivalent) for greater than or equal to (>=) 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).
Intention to treat (ITT) population includes all randomized participants in the analysis, according to the treatment group to which they were randomized, regardless of the treatment they actually received.
Posted
Number
percentage of participants
Week 26
ID
Title
Description
OG000
Azathioprine + Placebo
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
OG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
OG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Units
Counts
Participants
OG000170
OG001169
OG002169
Title
Denominators
Categories
Title
Measurements
OG00030.0
OG00144.4
OG00256.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline
<0.001
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With Mucosal Healing
Complete absence of mucosal ulcerations in the colon and terminal ileum as assessed by video endoscopy.
Analysis population for mucosal healing was per protocol. All subjects with lesions at Baseline (Week 0) and an Endoscopy at Week 26 were included in the analysis. Here, 'N' [number of participants analyzed] signifies those participants who were evaluable for this measure.
Posted
Number
percentage of participants
Week 26
ID
Title
Description
OG000
Azathioprine + Placebo
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
OG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Secondary
Percentage of Participants With Corticosteroid-free Clinical Remission (Study Extension)
Corticosteroid-free clinical remission is defined as a Crohn's Disease Activity Index (CDAI) < 150 who have not received any dose of systemic corticosteroids (prednisone or equivalent) for >= 3 weeks and have not received budesonide at a dose > 6 milligram per day (mg/day) for >= 3 weeks. The total CDAI score ranges from 0 - 600. The lower the CDAI score, the better (i.e., 0 is better and 600 is worse).
Population analyzed included all randomized participants enrolled in Study Extension.
Posted
Number
percentage of participants
Week 50
ID
Title
Description
OG000
Azathioprine + Placebo
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
OG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Secondary
Percentage of Participants With Clinical Remission (Main Study)
Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)
Population analyzed included all randomized participants enrolled in the main study.
Posted
Number
percentage of participants
Weeks 2, 6, 10, 18 and 26
ID
Title
Description
OG000
Azathioprine + Placebo
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
OG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Secondary
Percentage of Participants With Clinical Remission (Study Extension)
Clinical remission is defined as a CDAI < 150, compared to baseline (Week 0)
Population analyzed included all randomized participants enrolled in the Study Extension.
Posted
Number
percentage of participants
Weeks 34, 42 and 50
ID
Title
Description
OG000
Azathioprine + Placebo
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
OG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Secondary
Percentage of Participants With Clinical Response Over Time (Main Study)
Clinical response, defined as a >=100-point decrease in CDAI from Baseline.
Population analyzed included all randomized participants during the Main Study.
Posted
Number
percentage of participants
Weeks 2, 6, 10, 18, 26
ID
Title
Description
OG000
Azathioprine + Placebo
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
OG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Secondary
Percentage of Participants With Clinical Response Over Time (Study Extension)
Clinical response, defined as a >=100-point decrease in CDAI from Baseline.
Population analyzed included all randomized participants during the Study Extension.
Posted
Number
percentage of participants
Weeks 34, 42, 50
ID
Title
Description
OG000
Azathioprine + Placebo
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
OG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Secondary
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Weeks 2, 6, 10, 18 and 26 (Main Study)
Quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ). The IBDQ is a 32- item questionnaire and the total IBDQ score can range from 32 (very poor) to 224 (perfect).
Population analyzed included all randomized participants enrolled in Main Study with last observation carried forward method to impute missing data. 'n' signifies number of participants who were evaluable at specified time point, for each arm respectively.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 2, 6, 10, 18, 26
ID
Title
Description
OG000
Azathioprine + Placebo
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
OG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Secondary
Average Corticosteroid Use
Average daily dose of systemic corticosteroid concomitant medications(prednisone or equivalent)
Population analyzed included all randomized participants taking corticosteroids for Crohn's disease. n' signifies number of participants who were evaluable at specified time point, for each arm respectively.
Posted
Mean
Standard Deviation
milligram per day
Weeks 2, 6, 10, 18 and 26
ID
Title
Description
OG000
Azathioprine + Placebo
Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
OG001
Infliximab + Placebo
Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Time Frame
Not provided
Description
1 patient in AZA+PBO group(gp),3 in IFX+PBO gp,1 in IFX+AZA gp were randomized but not treated(Excluded from safety analyses).Safety population for IFX+AZA gp included 11 patients assigned to one of monotherapy gps but inadvertently were given at least one dose of both active oral and intravenous therapy(8 patients in AZA+PBO gp,3 in IFX+PBO gp).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
W30-Azathioprine + Placebo
Azathioprine (AZA) oral capsules 2.5 mg/kg/day and Placebo (PBO) infusion through Week 30.
39
161
120
161
EG001
W30-Infliximab + Placebo
Placebo (PBO) oral daily and Infliximab (IFX) infusions 5 mg/kg through Week 30.
26
163
122
163
EG002
W30-Infliximab + Azathioprine
Azathioprine (AZA) oral daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5mg/kg through Week 30.
25
179
133
179
EG003
W50-Azathioprine + Placebo
(AZA) oral daily 2.5 mg/kg/day and Placebo (PBO) infusion Week 30 through Week 50.
5
75
44
75
EG004
W50-Infliximab + Placebo
Placebo (PBO) oral capsules daily and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
15
97
69
97
EG005
W50-Infliximab + Azathioprine
Azathioprine (AZA) oral capsules daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
2
108
61
108
EG006
OLE-Azathioprine + Placebo/Infliximab
Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and Placebo (PBO) infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
1
8
7
8
EG007
OLE-Infliximab + Placebo/Infliximab
Placebo (PBO) oral capsules daily and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
1
18
16
18
EG008
OLE-Infliximab + Azathioprine/Infliximab
Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
3
17
15
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial Infarction
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG0030 affected75 at risk
EG0040 affected97 at risk
EG0050 affected108 at risk
EG0060 affected8 at risk
EG0070 affected18 at risk
EG0080 affected17 at risk
Vertigo
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Papilloedema
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0024 affected179 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Anal Fistula
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Colonic Stenosis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Crohn's Disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG00012 affected161 at risk
EG0017 affected163 at risk
EG0026 affected179 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Duodenal Stenosis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Duodenal Ulcer
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Duodenitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Enterocolonic Fistula
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Faecaloma
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Food Poisoning
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Gastrointestinal Fistula
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Ileal Stenosis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Intestinal Fistula
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Intestinal Perforation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Intestinal Stenosis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0004 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Pancreatitis Acute
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0004 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Peritonitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Small Intestinal Obstruction
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected161 at risk
EG0013 affected163 at risk
EG0021 affected179 at risk
EG003
Small Intestinal Stenosis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Asthenia
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Non-Cardiac Chest Pain
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Oedema Peripheral
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0021 affected179 at risk
EG003
Hepatitis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Hepatitis Acute
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Anaphylactoid Reaction
Immune system disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Abdominal Abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Abscess Intestinal
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Anal Abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Campylobacter Intestinal Infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Clostridium Difficile Colitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Erysipelas
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Pelvic Abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Perirectal Abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Pneumonia
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Pneumonia Legionella
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Pseudomembranous Colitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Psoas Abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Retroperitoneal Abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Sepsis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Tooth Infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Tuberculosis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Viral Infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Anastomotic Leak
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Crush Injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Hand Fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Hypovolaemia
Metabolism and nutrition disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Rotator Cuff Syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Benign Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Colon Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Cerebrovascular Accident
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Ischaemic Cerebral Infarction
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Migraine with Aura
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Paralysis
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Abortion Spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Ectopic Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Conversion Disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Psychotic Disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0021 affected179 at risk
EG003
Renal Colic
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Urethral Stenosis
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Urinary Retention
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Adenomyosis
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Female Genital Tract Fistula
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Ovarian Cyst
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Dyshidrosis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Skin Necrosis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Miscarriage of Partner
Social circumstances
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Haematoma
Vascular disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0005 affected161 at risk
EG0014 affected163 at risk
EG0022 affected179 at risk
EG0031 affected75 at risk
EG0042 affected97 at risk
EG0051 affected108 at risk
EG0060 affected8 at risk
EG0070 affected18 at risk
EG0081 affected17 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0003 affected161 at risk
EG0011 affected163 at risk
EG00210 affected179 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0011 affected163 at risk
EG0021 affected179 at risk
EG003
Angina Pectoris
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Palpitations
Cardiac disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0023 affected179 at risk
EG003
Ear Pain
Ear and labyrinth disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0013 affected163 at risk
EG0020 affected179 at risk
EG003
Amaurosis Fugax
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0021 affected179 at risk
EG003
Eyelids Pruritus
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Ocular Hyperaemia
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Panophthalmitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Uveitis
Eye disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Abdominal Discomfort
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Abdominal Distension
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0003 affected161 at risk
EG0017 affected163 at risk
EG0024 affected179 at risk
EG003
Abdominal Pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG00023 affected161 at risk
EG00134 affected163 at risk
EG00224 affected179 at risk
EG003
Abdominal Pain Upper
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0008 affected161 at risk
EG0018 affected163 at risk
EG00212 affected179 at risk
EG003
Anal Haemorrhage
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0022 affected179 at risk
EG003
Anal Ulcer
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Aphthous Stomatitis
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0021 affected179 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0005 affected161 at risk
EG0015 affected163 at risk
EG0025 affected179 at risk
EG003
Crohn's Disease
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG00014 affected161 at risk
EG0017 affected163 at risk
EG00210 affected179 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG00011 affected161 at risk
EG00114 affected163 at risk
EG00211 affected179 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0014 affected163 at risk
EG0029 affected179 at risk
EG003
Gastrointestinal Pain
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Gastrointestinal Sounds Abnormal
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0021 affected179 at risk
EG003
Intestinal Obstruction
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0021 affected179 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG00046 affected161 at risk
EG00127 affected163 at risk
EG00239 affected179 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Non-systematic Assessment
EG00024 affected161 at risk
EG00113 affected163 at risk
EG00214 affected179 at risk
EG003
Chest Discomfort
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0012 affected163 at risk
EG0020 affected179 at risk
EG003
Cyst
General disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Fatigue
General disorders
MedDRA
Non-systematic Assessment
EG00022 affected161 at risk
EG00121 affected163 at risk
EG00224 affected179 at risk
EG003
Inflammation
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Influenza Like Illness
General disorders
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0011 affected163 at risk
EG0023 affected179 at risk
EG003
Malaise
General disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Oedema Peripheral
General disorders
MedDRA
Non-systematic Assessment
EG0003 affected161 at risk
EG0013 affected163 at risk
EG0024 affected179 at risk
EG003
Pyrexia
General disorders
MedDRA
Non-systematic Assessment
EG00016 affected161 at risk
EG00110 affected163 at risk
EG00213 affected179 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Seasonal Allergy
Immune system disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0014 affected163 at risk
EG0020 affected179 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0012 affected163 at risk
EG0028 affected179 at risk
EG003
Ear Infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0011 affected163 at risk
EG0022 affected179 at risk
EG003
Fungal Infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0012 affected163 at risk
EG0020 affected179 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0013 affected163 at risk
EG0022 affected179 at risk
EG003
Gastroenteritis Viral
Infections and infestations
MedDRA
Non-systematic Assessment
EG0007 affected161 at risk
EG0013 affected163 at risk
EG0022 affected179 at risk
EG003
Herpes Zoster
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Impetigo
Infections and infestations
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Influenza
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0018 affected163 at risk
EG0026 affected179 at risk
EG003
Laryngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0021 affected179 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG00015 affected161 at risk
EG00113 affected163 at risk
EG00216 affected179 at risk
EG003
Oral Herpes
Infections and infestations
MedDRA
Non-systematic Assessment
EG0003 affected161 at risk
EG0014 affected163 at risk
EG0022 affected179 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0018 affected163 at risk
EG0022 affected179 at risk
EG003
Rhinitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0004 affected161 at risk
EG0012 affected163 at risk
EG0024 affected179 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0005 affected161 at risk
EG0012 affected163 at risk
EG0026 affected179 at risk
EG003
Tinea Pedis
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Tooth Abscess
Infections and infestations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0022 affected179 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0007 affected161 at risk
EG0013 affected163 at risk
EG0029 affected179 at risk
EG003
Vulvovaginal Mycotic Infection
Infections and infestations
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0012 affected163 at risk
EG0021 affected179 at risk
EG003
Arthropod Bite
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Epicondylitis
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Face Injury
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Ligament Rupture
Injury, poisoning and procedural complications
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Alanine Aminotransferase Increased
Investigations
MedDRA
Non-systematic Assessment
EG0003 affected161 at risk
EG0018 affected163 at risk
EG0026 affected179 at risk
EG003
Aspartate Aminotransferase Increased
Investigations
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0016 affected163 at risk
EG0026 affected179 at risk
EG003
Blood Albumin Abnormal
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Blood Alkaline Phosphatase Increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
C-Reactive Protein Abnormal
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
C-Reactive Protein Increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Hepatic Enzyme Increased
Investigations
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0011 affected163 at risk
EG0023 affected179 at risk
EG003
Liver Function Test Abnormal
Investigations
MedDRA
Non-systematic Assessment
EG0003 affected161 at risk
EG0011 affected163 at risk
EG0022 affected179 at risk
EG003
Weight Increased
Investigations
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG00014 affected161 at risk
EG00123 affected163 at risk
EG00217 affected179 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0007 affected161 at risk
EG0016 affected163 at risk
EG0025 affected179 at risk
EG003
Lupus-Like Syndrome
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Muscle Rigidity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Musculoskeletal Stiffness
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0023 affected179 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0006 affected161 at risk
EG0018 affected163 at risk
EG0022 affected179 at risk
EG003
Neck Pain
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0012 affected163 at risk
EG0020 affected179 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Pain in Extremity
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0015 affected163 at risk
EG0022 affected179 at risk
EG003
Plantar Fasciitis
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Spondyloarthropathy
Musculoskeletal and connective tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Benign Neoplasm of Skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0006 affected161 at risk
EG00111 affected163 at risk
EG00210 affected179 at risk
EG003
Headache
Nervous system disorders
MedDRA
Non-systematic Assessment
EG00019 affected161 at risk
EG00122 affected163 at risk
EG00222 affected179 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0003 affected161 at risk
EG0014 affected163 at risk
EG0020 affected179 at risk
EG003
Lethargy
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Syncope Vasovagal
Nervous system disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0022 affected179 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0013 affected163 at risk
EG0022 affected179 at risk
EG003
Depressed Mood
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0021 affected179 at risk
EG003
Depression
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0004 affected161 at risk
EG0015 affected163 at risk
EG0021 affected179 at risk
EG003
Fear
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0005 affected161 at risk
EG0014 affected163 at risk
EG0021 affected179 at risk
EG003
Sleep Disorder
Psychiatric disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0012 affected163 at risk
EG0022 affected179 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA
Non-systematic Assessment
EG0004 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Chronic Obstructive Pulmonary Disease
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0007 affected161 at risk
EG00111 affected163 at risk
EG0022 affected179 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0021 affected179 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0013 affected163 at risk
EG0025 affected179 at risk
EG003
Oropharyngeal Pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0005 affected161 at risk
EG00112 affected163 at risk
EG0025 affected179 at risk
EG003
Productive Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0002 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Sinus Disorder
Respiratory, thoracic and mediastinal disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0003 affected161 at risk
EG0013 affected163 at risk
EG0024 affected179 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0004 affected161 at risk
EG0017 affected163 at risk
EG0027 affected179 at risk
EG003
Dry Skin
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0012 affected163 at risk
EG0021 affected179 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0024 affected179 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0022 affected179 at risk
EG003
Exfoliative Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Night Sweats
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0004 affected161 at risk
EG0011 affected163 at risk
EG0022 affected179 at risk
EG003
Pain of Skin
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Photosensitivity Reaction
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Pityriasis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0005 affected161 at risk
EG0012 affected163 at risk
EG0023 affected179 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0009 affected161 at risk
EG0017 affected163 at risk
EG0029 affected179 at risk
EG003
Seborrhoeic Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Pregnancy of Partner
Social circumstances
MedDRA
Non-systematic Assessment
EG0001 affected161 at risk
EG0010 affected163 at risk
EG0020 affected179 at risk
EG003
Tooth Extraction
Surgical and medical procedures
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0010 affected163 at risk
EG0021 affected179 at risk
EG003
Haematoma
Vascular disorders
MedDRA
Non-systematic Assessment
EG0000 affected161 at risk
EG0011 affected163 at risk
EG0020 affected179 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Non-systematic Assessment
EG0003 affected161 at risk
EG0015 affected163 at risk
EG0023 affected179 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Centocor Ortho Biotech Services, L.L.C.
215 325-7405
ID
Term
D003424
Crohn Disease
Ancestor Terms
ID
Term
D015212
Inflammatory Bowel Diseases
D005759
Gastroenteritis
D005767
Gastrointestinal Diseases
D004066
Digestive System Diseases
D007410
Intestinal Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000069285
Infliximab
D001379
Azathioprine
D002214
Capsules
Ancestor Terms
ID
Term
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D000602
Amino Acids, Peptides, and Proteins
D012712
Serum Globulins
D005916
Globulins
D013872
Thionucleosides
D013457
Sulfur Compounds
D009930
Organic Chemicals
D015122
Mercaptopurine
D011687
Purines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
D009705
Nucleosides
D009706
Nucleic Acids, Nucleotides, and Nucleosides
D004304
Dosage Forms
D004364
Pharmaceutical Preparations
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Withdrawal by Subject
FG0002 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0003 subjects
FG0019 subjects
FG0027 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Other
FG0001 subjects
FG0012 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
13 subjects
FG00513 subjects
5 subjects
FG0054 subjects
0 subjects
FG0043 subjects
FG0054 subjects
Inadequate therapeutic effect
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0041 subjects
FG0050 subjects
Patient decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0050 subjects
36.3
± 12.62
81
BG003246
Male
BG00090
BG00184
BG00288
BG003262
8
BG00325
BELGIUM
Title
Measurements
BG00014
BG00117
BG00215
BG00346
CANADA
Title
Measurements
BG0009
BG0017
BG0027
BG00323
DENMARK
Title
Measurements
BG0005
BG0018
BG0024
BG00317
FRANCE
Title
Measurements
BG0009
BG00112
BG00218
BG00339
GERMANY
Title
Measurements
BG00017
BG0018
BG00213
BG00338
GREECE
Title
Measurements
BG0003
BG0013
BG0023
BG0039
ISRAEL
Title
Measurements
BG0007
BG00113
BG00212
BG00332
NETHERLANDS
Title
Measurements
BG0009
BG0019
BG0028
BG00326
NORWAY
Title
Measurements
BG0000
BG0011
BG0020
BG0031
PORTUGAL
Title
Measurements
BG0000
BG0012
BG0020
BG0032
SPAIN
Title
Measurements
BG0002
BG0012
BG0022
BG0036
SWEDEN
Title
Measurements
BG0000
BG0011
BG0022
BG0033
UK
Title
Measurements
BG0004
BG00111
BG0027
BG00322
USA
Title
Measurements
BG00083
BG00166
BG00270
BG003219
The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline
0.006
No
Superiority or Other
OG001
OG002
Cochran-Mantel-Haenszel
The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline
0.022
No
Superiority or Other
OG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Units
Counts
Participants
OG000109
OG00193
OG002107
Title
Denominators
Categories
Title
Measurements
OG00016.5
OG00130.1
OG00243.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Cochran-Mantel-Haenszel
The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline
<0.001
95
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline
0.023
95
No
Superiority or Other
OG001
OG002
Cochran-Mantel-Haenszel
The P-Value is from a CMH test stratified by duration of Crohn's disease and corticosteroid treatment at Baseline
0.055
95
No
Superiority or Other
OG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Units
Counts
Participants
OG00075
OG00197
OG002108
Title
Denominators
Categories
Title
Measurements
OG00054.7
OG00160.8
OG00272.2
OG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Units
Counts
Participants
OG000170
OG001169
OG002169
Title
Denominators
Categories
Week 2
Title
Measurements
OG00017.6
OG00132.5
OG00236.7
Week 6
Title
Measurements
OG00027.6
OG00149.1
OG00252.1
Week 10
Title
Measurements
OG00034.1
OG00147.3
OG00259.8
Week 18
Title
Measurements
OG00033.5
OG00149.7
OG00260.4
Week 26
Title
Measurements
OG00031.8
OG00147.9
OG00260.4
OG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Units
Counts
Participants
OG00075
OG00197
OG002108
Title
Denominators
Categories
Week 34
Title
Measurements
OG00061.3
OG00166.0
OG00269.4
Week 42
Title
Measurements
OG00058.7
OG00172.2
OG00273.1
Week 50
Title
Measurements
OG00054.7
OG00166.0
OG00274.1
OG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Units
Counts
Participants
OG000170
OG001169
OG002169
Title
Denominators
Categories
Week 2
Title
Measurements
OG00022.4
OG00142.6
OG00247.3
Week 6
Title
Measurements
OG00037.6
OG00154.4
OG00263.3
Week 10
Title
Measurements
OG00039.4
OG00155.6
OG00269.2
Week 18
Title
Measurements
OG00038.8
OG00155.0
OG00262.7
Week 26
Title
Measurements
OG00037.6
OG00154.4
OG00262.1
OG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Units
Counts
Participants
OG00075
OG00197
OG002108
Title
Denominators
Categories
Week 34
Title
Measurements
OG00066.7
OG00176.3
OG00276.9
Week 42
Title
Measurements
OG00065.3
OG00174.2
OG00277.8
Week 50
Title
Measurements
OG00062.7
OG00172.2
OG00278.7
OG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
Units
Counts
Participants
OG000170
OG001169
OG002169
Title
Denominators
Categories
Week 2 (n= 160, 160, 163)
Title
Measurements
OG00020.1± 24.29
OG00127.7± 26.08
OG00231.4± 29.60
Week 6 (n= 162, 161, 165)
Title
Measurements
OG00028.3± 31.25
OG00134.8± 31.79
OG00239.9± 32.90
Week 10 (n= 162, 161, 165)
Title
Measurements
OG00031.0± 31.66
OG00137.8± 35.56
OG00242.4± 34.67
Week 18 (n= 162, 161, 165)
Title
Measurements
OG00030.3± 33.92
OG00139.9± 34.17
OG00243.7± 34.56
Week 26 (n= 162, 161, 165)
Title
Measurements
OG00031.4± 35.43
OG00139.9± 36.62
OG00245.2± 35.76
OG002
Infliximab + Azathioprine
Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.