Long-term Safety and Tolerability Study of Adalimumab in... | NCT00195715

Official Title

A Multi Center, Open Label Study of the Human Anti TNF Monoclonal Antibody Adalimumab to Evaluate the Long Term Safety and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease

Status Module

Sponsor/Collaborators Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab	Biological	Adalimumab 40 mg by subcutaneous injection every other week or every week		ABT-D2E7 Humira

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects Achieving Clinical Remission	Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.	Week 156

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects Achieving Clinical Remission	Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.	Week 48
Percentage of Subjects Achieving Clinical Remission

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Anne Camez, MD	Abbott	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Site Ref # / Investigator 1894		Huntsville	Alabama	35801	United States
Site Ref # / Investigator 1895

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29380251	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.
22704916	Derived	Schreiber S, Reinisch W, Colombel JF, Sandborn WJ, Hommes DW, Robinson AM, Huang B, Lomax KG, Pollack PF. Subgroup analysis of the placebo-controlled CHARM trial: increased remission rates through 3 years for adalimumab-treated patients with early Crohn's disease. J Crohns Colitis. 2013 Apr;7(3):213-21. doi: 10.1016/j.crohns.2012.05.015. Epub 2012 Jun 16.

Results Section

Participant Flow Module

ID	Title	Description
FG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

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
	BG00038.0± 11.75

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000485
Male	BG000292

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000349

Australia

Title	Measurements
	BG000

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

Secondary

Percentage of Subjects Achieving Clinical Remission

Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of < 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

Intent-to-treat, Observed Cases

Posted

Number

Percentage of participants

Week 48

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000609

Title

Denominators

Categories

Title	Measurements
	OG00059.4

Secondary

Percentage of Subjects Achieving Clinical Remission

Intent-to-treat, Observed Cases

Posted

Number

Percentage of participants

Week 108

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000462

Primary

Percentage of Subjects Achieving Clinical Remission

Intent-to-treat, defined as all subjects who received at least 1 dose of study drug; Observed Cases

Posted

Number

Percentage of participants

Week 156

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Achieving Clinical Remission

Intent-to-treat, Observed Cases

Posted

Number

Percentage of participants

Week 204

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG00015

Secondary

Percentage of Subjects Achieving Clinical Response 100 (CR-100)

A CR-100 is a decrease from baseline in CDAI score of 100 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

Intent-to-treat, Observed Cases

Posted

Number

Percentage of participants

Week 156

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000272

Secondary

Percentage of Subjects Achieving Clinical Response 70 (CR-70)

A CR-70 is a decrease from baseline in CDAI score of 70 or more points. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

Intent-to-treat, Observed Cases

Posted

Number

Percentage of participants

Week 156

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000272

Secondary

Percentage of Subjects Achieving Steroid-free Clinical Remission

Steroid-free remission was achieved if the subject stopped taking steroids before the visit and had a Crohn's Disease Activity Index (CDAI) score of <150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

Intent-to-treat, Subjects with steroid use at baseline of preceding study, Observed Cases

Posted

Number

Percentage of participants

Week 156

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Achieving Steroid-free CR-100

Steroid-free CR-100 was achieved if the subject stopped taking steroids before the visit and had a decrease from baseline in CDAI score of 100 or more points at that visit. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.

Intent-to-treat, Subjects with corticosteroid use at baseline of preceding study, Observed Cases

Posted

Number

Percentage of participants

Week 156

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Fistula Remission

Fistula remission was defined as the absence of draining fistulas in subjects with fistula present at the preceding study's baseline visit.

Intent-to-treat, Subjects with fistulas present at baseline of the preceding study, Observed Cases

Posted

Number

Percentage of participants

Week 156

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG00043

Secondary

Percentage of Subjects With Infection

Safety population, defined as all subjects who received at least 1 dose of study drug

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators

Secondary

Percentage of Subjects With Serious Infection

Serious infections are infectious adverse events that meet at least one criterion for a serious adverse event (e.g., death, life threatening event, hospitalization) including tuberculosis (TB), bacterial sepsis, invasive fungal infections (e.g., histoplasmosis), and infections due to other opportunistic pathogens.

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Malignancy

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Lymphoma

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Nonmelanoma Skin Cancer

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Malignancy (Excluding Nonmelanoma Skin Cancer and Lymphoma)

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Malignancy (Including Lymphoma, Excluding Nonmelanoma Skin Cancer)

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators

Secondary

Percentage of Subjects With Injection Site Reaction-related Adverse Event

An injection site reaction is any adverse event corresponding to a preferred term beginning with "injection site" excluding injection site arthritis, injection site movement impairment, injection site photosensitivity, injection site joint effusion, injection site joint inflammation, injection site scab, injection site joint pain, or injection site laceration.

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Opportunistic Infection (Excluding Tuberculosis)

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Congestive Heart Failure

Safety population

Posted

Number

Percentage of subjects

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Demyelinating Disease

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Hepatic-related Adverse Event

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Allergic Reaction-related Adverse Event

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Lupus-like Syndrome

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Hematologic-related Adverse Event

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

Secondary

Percentage of Subjects With Fatal Adverse Event

Safety population

Posted

Number

Percentage of participants

Up to 262 weeks of adalimumab treatment

ID	Title	Description
OG000	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week

Units	Counts
Participants	OG000777

Title	Denominators	Categories

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	Open-label Adalimumab	40 mg by subcutaneous injection every other week or every week			296	777	720	777

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0005 affected777 at risk
Abdominal adhesions	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Abdominal mass	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00011 affected777 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Abdominal rigidity	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Abdominal sepsis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Abortion induced	Surgical and medical procedures	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Abortion of ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Abscess intestinal	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Abscess limb	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Acute pulmonary histoplasmosis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected777 at risk
Anal abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00015 affected777 at risk
Anal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0008 affected777 at risk
Anal stenosis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Angina unstable	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Anorectal disorder	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Anxiety	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Appendicitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Arthritis infective	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Ascites	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Axillary vein thrombosis	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Basedow's disease	Endocrine disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Bipolar disorder	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Breast cellulitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Breast enlargement	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Breast hyperplasia	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Bronchitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
C-reactive protein increased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Campylobacter infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Carotid artery disease	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Catheter sepsis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Cellulitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Cervicitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Chest pain	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Chills	General disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Clostridial infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Coccidioidomycosis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Colitis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Colonic pseudo-obstruction	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Colonic stenosis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Colpocele	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Constipation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected777 at risk
Convulsion	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00092 affected777 at risk
Cystocele	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0007 affected777 at risk
Demyelination	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Dental caries	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Depression	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0005 affected777 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Drug dependence	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Enteritis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Escherichia infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Faecal volume increased	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Fatigue	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Feeling cold	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Female genital tract fistula	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Fistula discharge	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Gastritis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0005 affected777 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Gastrointestinal fistula	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Goitre	Endocrine disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Granuloma annulare	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Haematocrit decreased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Haemoglobin decreased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Hepatic neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Hernia	General disorders	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Herpes zoster	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Hypersensitivity	Immune system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Hypertension	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Hypotension	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Ileal perforation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Ileal stenosis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 affected777 at risk
Ileus	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Insomnia	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Intestinal fistula	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00010 affected777 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Intestinal stenosis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Iron deficiency	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Jejunal perforation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Joint contracture	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Lobar pneumonia	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Lupus-like syndrome	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Mammoplasty	Surgical and medical procedures	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Medical device complication	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Medical device removal	Surgical and medical procedures	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Megacolon	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Mesenteric vein thrombosis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Muscle abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Myocardial infarction	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0006 affected777 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0006 affected777 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Non-cardiac chest pain	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Obstruction	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Optic neuritis	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Otitis media	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0005 affected777 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Pain	General disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Palpitations	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Perineal abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Peripheral coldness	General disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Perirectal abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0005 affected777 at risk
Peritonitis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Peritonsillar abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Photophobia	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Physical assault	Social circumstances	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Pneumonia	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0008 affected777 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Pneumonia fungal	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Post procedural infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Procedural site reaction	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Proctalgia	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Pyelonephritis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0005 affected777 at risk
Pyrexia	General disorders	MedDRA (11.1)	Systematic Assessment	EG0006 affected777 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Rectal abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Rectocele	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Red blood cell sedimentation rate increased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Scrotal abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Sepsis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0004 affected777 at risk
Septic shock	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Sinusitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Skin discolouration	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00030 affected777 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Small intestinal stenosis	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Small intestine ulcer	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Staphylococcal infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Substance abuse	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Suicide attempt	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Urinary tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 affected777 at risk
Urogram normal	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Vaginal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0002 affected777 at risk
Venous thrombosis	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Vertebral injury	Injury, poisoning and procedural complications	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Viral infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Vision blurred	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Visual impairment	Eye disorders	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Vomiting	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0006 affected777 at risk
Vulval abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk
Weight decreased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0001 affected777 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00065 affected777 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG000180 affected777 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00045 affected777 at risk
Abdominal tenderness	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00045 affected777 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG00046 affected777 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00045 affected777 at risk
Anxiety	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG00054 affected777 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG000192 affected777 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00087 affected777 at risk
Bronchitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00092 affected777 at risk
Constipation	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00081 affected777 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00082 affected777 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG000309 affected777 at risk
Depression	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG00070 affected777 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG000118 affected777 at risk
Dizziness	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG00054 affected777 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00064 affected777 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00052 affected777 at risk
Fatigue	General disorders	MedDRA (11.1)	Systematic Assessment	EG000107 affected777 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00040 affected777 at risk
Flatulence	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00044 affected777 at risk
Gastroenteritis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00058 affected777 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00042 affected777 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00054 affected777 at risk
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG000141 affected777 at risk
Hypertension	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG00044 affected777 at risk
Influenza	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG000137 affected777 at risk
Influenza like illness	General disorders	MedDRA (11.1)	Systematic Assessment	EG00048 affected777 at risk
Injection site irritation	General disorders	MedDRA (11.1)	Systematic Assessment	EG00046 affected777 at risk
Injection site pain	General disorders	MedDRA (11.1)	Systematic Assessment	EG00043 affected777 at risk
Injection site reaction	General disorders	MedDRA (11.1)	Systematic Assessment	EG00060 affected777 at risk
Insomnia	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG00081 affected777 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00043 affected777 at risk
Nasopharyngitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG000203 affected777 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG000142 affected777 at risk
Oedema peripheral	General disorders	MedDRA (11.1)	Systematic Assessment	EG00047 affected777 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG00084 affected777 at risk
Pain	General disorders	MedDRA (11.1)	Systematic Assessment	EG00045 affected777 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00047 affected777 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG00050 affected777 at risk
Pyrexia	General disorders	MedDRA (11.1)	Systematic Assessment	EG000105 affected777 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (11.1)	Systematic Assessment	EG000100 affected777 at risk
Sinusitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG000116 affected777 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG000150 affected777 at risk
Urinary tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00080 affected777 at risk
Viral infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG00040 affected777 at risk
Vomiting	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00082 affected777 at risk

This study was stopped by the sponsor in December 2008 when the pre-specified termination criteria were met. Subjects who continued in the study through the termination date were considered as having completed the study.

Certain Agreements

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
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

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases