Remission in Subjects With Crohn's Disease, 1 Year Phase | NCT00055497

Label	Type	Description	Intervention Names
Double-blind (DB) adalimumab placebo	Placebo Comparator	Double-blind nonactive matching subcutaneous injection	Biological: Double-blind (DB) adalimumab placebo
Double-blind adalimumab 40 mg every other week (eow)	Experimental	Double-blind adalimumab 40 mg eow by subcutaneous injection	Biological: DB adalimumab 40 mg eow
Double-blind adalimumab 40 mg every week (ew)	Experimental	Double-blind adalimumab 40 mg every week by subcutaneous injection	Biological: DB adalimumab 40 mg ew
Open-label adalimumab 40 mg	Experimental	Open-label adalimumab 40 mg eow or ew by subcutaneous injection	Biological: OL adalimumab 40 mg

Name	Type	Description	Arm Group Labels	Other Names
Double-blind (DB) adalimumab placebo	Biological	Double-blind nonactive matching subcutaneous injection	Double-blind (DB) adalimumab placebo

Measure	Description	Time Frame
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)	Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.	Week 56
Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)	Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.	Week 56

Measure	Description	Time Frame
Number of Participants Achieving Clinical Remission at Week 24 - NRI	Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.

Name	Affiliation	Role
Anne Camez, MD	Abbott	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Gastroenterology Associates of the East Bay		Berkeley	California	94705	United States
Long Beach Gastroenterology Assoc.

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.
22344964	Derived	Steenholdt C, Al-khalaf M, Brynskov J, Bendtzen K, Thomsen OO, Ainsworth MA. Clinical implications of variations in anti-infliximab antibody levels in patients with inflammatory bowel disease. Inflamm Bowel Dis. 2012 Dec;18(12):2209-17. doi: 10.1002/ibd.22910. Epub 2012 Feb 16.

ID	Title	Description
FG000	DB Placebo	Double-blind adalimumab placebo every week.
FG001	DB Adalimumab 40 mg Every Other Week (Eow)	Double-blind adalimumab 40 mg every other week (injection received every week; placebo received when active drug not received)

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

Number of Participants Achieving Clinical Remission at Week 24 - NRI

Clinical remission is defined as CDAI score <150. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.

Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.

Posted

Number

Participants

Week 24

ID	Title	Description
OG000	DB Placebo
OG001	DB Adalimumab 40 mg Every Other Week (Eow)
OG002	DB Adalimumab 40 mg Every Week (ew)
OG003	OL Adalimumab 40 mg Eow

Units	Counts
Participants	OG00018 OG00119 OG00218 OG003

Title

Denominators

Categories

Title	Measurements
	OG0007 OG00111 OG00217 OG003

Secondary

Number of OL Participants Achieving Clinical Remission at Week 56 - NRI

Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Nonresponder imputation (NRI) (CR-100 not achieved) was used for missing data.

Posted

Number

Participants

Week 56

ID	Title	Description
OG000	OL Adalimumab 40 mg	Open-label adalimumab 40 mg every other week or every week

Units	Counts
Participants	OG000

Primary

Number of Randomized Participants Achieving Clinical Remission at Week 56 - Non-Responder Imputation (NRI)

Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Nonresponder imputation (NRI) (clinical remission not achieved) was used for missing data.

Posted

Number

Participants

Week 56

ID	Title	Description
OG000	Placebo
OG001	DB Adalimumab 40 mg Every Other Week (Eow)
OG002	DB Adalimumab 40 mg Every Week (ew)

Units	Counts
Participants

Primary

Number of Randomized Participants Achieving Clinical Remission at Week 56 - Last Observation Carried Forward (LOCF)

Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Last observation carried forward was used for missing data.

Posted

Number

Participants

Week 56

ID	Title	Description
OG000	DB Placebo
OG001	DB Adalimumab 40 mg Every Other Week (Eow)
OG002	DB Adalimumab 40 mg Every Week (ew)

Units	Counts
Participants

Secondary

Number of Participants Achieving Clinical Response 100 (CR-100) - NRI

A CR-100 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 100 or more points, indicating significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.

Posted

Number

Participants

From Baseline of lead-in study to Week 24 and Week 56

ID	Title	Description
OG000	DB Placebo
OG001	DB Adalimumab 40 mg Eow
OG002	DB Adalimumab 40 mg ew
OG003	OL Adalimumab 40 mg Eow

Secondary

Number of Participants Achieving Clinical Response 70 (CR-70)- NRI

A CR-70 is a decrease from Baseline of lead-in study (NCT00055523) in CDAI score of 70 or more points, indicating a significant improvement in disease severity. CDAI evaluates 8 Crohn's-related variables during a 1-week assessment period, yielding a composite score >/= 0 and without upper limit. The range of scores during Study NCT00055497 and the lead-in study (NCT00055523) was 0 to 633. A lower score indicates less severe Crohn's disease activity.

Posted

Number

Participants

From Baseline of lead-in study to Week 24 and to Week 56

ID	Title	Description
OG000	DB Placebo
OG001	DB Adalimumab 40 mg Eow
OG002	DB Adalimumab 40 mg ew
OG003	OL Adalimumab 40 mg Eow

Secondary

Number of Participants Achieving Clinical Remission at Week 24 - LOCF

Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Participants in the OL adalimumab group were all participants who were assigned to the OL treatment and continued past Week 4. Last observation carried forward (LOCF) was used for missing data.

Posted

Number

Participants

Week 24

ID	Title	Description
OG000	DB Placebo
OG001	DB Adalimumab 40 mg Every Other Week (Eow)
OG002	DB Adalimumab 40 mg Every Week (ew)
OG003	OL Adalimumab 40 mg Eow

Secondary

Number of OL Participants Achieving Clinical Remission at Week 56 - LOCF

Posted

Number

Participants

Week 56

ID	Title	Description
OG000	OL Adalimumab 40 mg

Units	Counts
Participants	OG000204

Secondary

Number of Participants Achieving CR-100 - LOCF

Subjects randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. Subjects in the OL adalimumab group were all subjects who were assigned to the OL treatment and continued past Week 4. LOCF was used for missing data.

Posted

Number

Participants

From Baseline of lead-in study to Week 24 and Week 56

ID	Title	Description
OG000	DB Placebo
OG001	DB Adalimumab 40 mg Every Other Week (Eow)
OG002	DB Adalimumab 40 mg Every Week (ew)
OG003	OL Adalimumab 40 mg Eow

Secondary

Number of Participants Achieving CR-70 - LOCF

Posted

Number

Participants

From Baseline of lead-in study to Week 24 and Week 56

ID	Title	Description
OG000	DB Placebo
OG001	DB Adalimumab 40 mg Every Other Week (Eow)
OG002	DB Adalimumab 40 mg Every Week (ew)
OG003	OL Adalimumab 40 mg Eow

Secondary

Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Scores - LOCF

IBDQ is a validated disease-specific instrument that assesses the impact of IBD on patient quality of life during a 2-week recall period. It has 32 questions about bowel function and related symptoms, and their social and emotional impact. For each question, participants selected 1 of 7 responses, where 1=poor quality of life (e.g., feeling of fatigue "all of the time") and 7=good quality on the item (e.g., feeling of fatigue "none of the time"). IBDQ scores range from 32 to 224. Higher scores indicate better quality of life, and increases in IBDQ indicate improved overall quality of life.

Participants randomized to DB treatment who received at least one injection of blinded study drug were included in assigned treatment group. OL adalimumab group was all participants assigned to the OL treatment who continued past Week 4. LOCF was used for missing data. 4 participants in OL group did not have IBDQ data at Baseline of lead-in study.

Posted

Mean

95% Confidence Interval

Scores on a scale

Change from Baseline of lead-in study to Week 24 and Week 56

ID	Title	Description
OG000	DB Placebo
OG001	DB Adalimumab 40 mg Every Other Week (Eow)
OG002	DB Adalimumab 40 mg Every Week (ew)
OG003

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal abscess	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG0032 affected221 at risk
Abscess	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Abscess intestinal	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Anemia NOS aggravated	Blood and lymphatic system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Calculus renal	Renal and urinary disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Cerebrovascular accident	Vascular disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Diverticulitis	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Dizziness (excl vertigo)	Nervous system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Fatigue	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Fifth disease	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Headache	Nervous system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Ileal stenosis	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Intervertebral disc herniation	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Intestinal stenosis NOS	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Meningitis viral	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Nocardiosis	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Pain	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Pyloric stenosis	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Rectal abscess	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Retroperitoneal abscess	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Sepsis	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Small intestinal stricture	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Sweating increased	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal distension	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG0039 affected221 at risk
Abdominal pain aggravated	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0012 affected19 at risk EG0020 affected18 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0021 affected18 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Anxiety aggravated	Psychiatric disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0012 affected19 at risk EG0021 affected18 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Chest tightness aggravated	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0003 affected18 at risk EG0011 affected19 at risk EG0021 affected18 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Crohn's disease aggravated	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0005 affected18 at risk EG0014 affected19 at risk EG0022 affected18 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0021 affected18 at risk EG003
Dizziness (excl vertigo)	Nervous system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0022 affected18 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Fatigue	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0011 affected19 at risk EG0021 affected18 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Headache	Nervous system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Influenza	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0013 affected19 at risk EG0021 affected18 at risk EG003
Injection site oedema	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Injection site reaction	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0012 affected19 at risk EG0020 affected18 at risk EG003
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0007 affected18 at risk EG0015 affected19 at risk EG0022 affected18 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0012 affected19 at risk EG0021 affected18 at risk EG003
Pharyngolaryngeal pain	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0012 affected19 at risk EG0020 affected18 at risk EG003
Pain in limb	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Pruritis	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Pyrexia	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0012 affected19 at risk EG0021 affected18 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0021 affected18 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0022 affected18 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Viral infection	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0014 affected19 at risk EG0020 affected18 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0021 affected18 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Conjunctivitis	Eye disorders	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Episcleritis	Eye disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Iritis	Eye disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Pterygium	Eye disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Vision abnormal	Eye disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0003 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Anal inflammation	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Anal skin tags	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Anal ulcer	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Faecal incontinence	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Oesophageal pain	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Tooth impacted	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Adverse drug reaction	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Application site pain	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Asthenia	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Axillary mass	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Bloody drainage	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Fall	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Fatigue aggravated	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Ill-defined disorder	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Influenza like illness	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Malaise	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Oedema	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Pain	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Tenderness	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Abscess	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Arthropod infestation	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Bronchitis acute	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Cellulitis	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Dry socket	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Folliculitis	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Ear infection	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Fungal infection	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Herpes simplex	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Laryngitis	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Otitis media	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Pathogen resistance	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Perineal abscess	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Sinusitis	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0014 affected19 at risk EG0021 affected18 at risk EG003
Vaginal abscess	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Vaginal candidiasis	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Wound infection	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Abrasion	Injury, poisoning and procedural complications	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Accident	Injury, poisoning and procedural complications	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0012 affected19 at risk EG0020 affected18 at risk EG003
Joint sprain	Injury, poisoning and procedural complications	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0012 affected19 at risk EG0020 affected18 at risk EG003
Procedural site reaction	Injury, poisoning and procedural complications	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Antinuclear factor positive	Investigations	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Blood creatine phophokinase increased	Investigations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Double-stranded DNA antibody	Investigations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Eosinophil count increased	Investigations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Liver function tests abnormal	Investigations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Lymphocyte morphology abnormal	Investigations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Monocyte count increased	Investigations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Neutrophil count increased	Investigations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Platelet count decreased	Investigations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
White blood cell count decreased	Investigations	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Arthritis enteropathic	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Fistula	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Joint stiffness	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Polyarthralgia	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Sciatica aggravated	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Temporomandibular joint disorder	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Diabetes mellitus aggravated	Metabolism and nutrition disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Dystrophic calcification	Musculoskeletal and connective tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Hypercholesterolaemia aggravated	Metabolism and nutrition disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Lactose intolerance	Metabolism and nutrition disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Headache aggravated	Nervous system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Sinus headache	Nervous system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Sleep apnoea syndrome	Nervous system disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Acute stress disorder	Psychiatric disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Adjustment disorder	Psychiatric disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Insomnia exacerbated	Psychiatric disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Sleep disorder	Psychiatric disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Difficulty in micturition	Renal and urinary disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Breast pain	Reproductive system and breast disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Nipple pain	Reproductive system and breast disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Chronic obstructive airways disease	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0012 affected19 at risk EG0021 affected18 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Nasal passage irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Acrochordons	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Night sweats	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Palmar erythema	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Skin desquamation	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Skin nodule	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Continuous positive airway pressure	Surgical and medical procedures	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Endodontic procedure	Surgical and medical procedures	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Vasectomy	Surgical and medical procedures	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Ecchymosis	Vascular disorders	MedDRA (4.0)	Non-systematic Assessment	EG0001 affected18 at risk EG0010 affected19 at risk EG0020 affected18 at risk EG003
Petechiae	Vascular disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Mass	General disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Rhinovirus infection	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Defaecation urgency	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (4.0)	Non-systematic Assessment	EG0002 affected18 at risk EG0011 affected19 at risk EG0020 affected18 at risk EG003
Subcutaneous nodule	Skin and subcutaneous tissue disorders	MedDRA (4.0)	Non-systematic Assessment	EG0000 affected18 at risk EG0010 affected19 at risk EG0021 affected18 at risk EG003

ID	Title	Description
BG000	DB Placebo
BG001	DB Adalimumab 40 mg Every Other Week (Eow)
BG002	DB Adalimumab 40 mg Every Week
BG003	OL Adalimumab 40 mg Eow	Participants who did not continue at Week 4 are not included in Baseline summary.
BG004	Total	Total of all reporting groups

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

ID	Term
D015340	Epidemiologic Research Design
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D012107	Research Design
D008722	Methods
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care
D017530	Health Care Quality, Access, and Evaluation
D011634	Public Health
D004778	Environment and Public Health
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	Title	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	DB Placebo	2	18	18	18
EG001	DB Adalimumab 40 mg Eow	1	19	15	19
EG002	DB Adalimumab 40 mg ew	0	18	14	18
EG003	OL Adalimumab 40 mg	37	221	190	221