A Study to Evaluate Safety of Long Term Therapy of Certol... | NCT00552344

ID	Type	Description	Link
2007-002716-26	EudraCT Number

Status Module

Name	Class
PPD Development, LP	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Certolizumab Pegol	Experimental	Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.	Biological: Cimzia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cimzia	Biological	Active substance: Certolizumab Pegol Pharmaceutical form:first reconstituted, lyophilized powder formulation of CZP and after implementation of Amendment 2 (after 401 subjects were enrolled) prefilled syringe Concentration: 200 mg/ml Route of Administration: Subcutaneous use

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)	An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	From study start to the end of the Safety Follow-up Period (up to 272 weeks)
Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)	An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.	From study start to the end of the Safety Follow-up Period (up to 272 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)	HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.

Eligibility Module

Name	Affiliation	Role
UCB Clinical Trial Call Center	+1 877 822 9493 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
284		Lakewood	Colorado		United States
285

Results Section

Participant Flow Module

ID	Title	Description
FG000	Certolizumab Pegol	Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

Participants

Title

Denominators

Categories

18 - < 65 years

Title	Measurements
	BG000393

65 - < 85 years

Title	Measurements
	BG0009

>= 85 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00037.3± 12.68

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000221
Male	BG000181

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Subjects With at Least One Adverse Event (AE) During the Duration of the Study C87088 (up to 272 Weeks)

An AE is defined as any untoward medical occurrence in a subject or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.

Posted

Number

percentage of subjects

From study start to the end of the Safety Follow-up Period (up to 272 weeks)

ID	Title	Description
OG000	Certolizumab Pegol	Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

Units	Counts
Participants	OG000402

Title

Denominators

Categories

Title	Measurements
	OG00089.6

Primary

Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of the Study C87088 (up to 272 Weeks)

An SAE is defined as any untoward medical occurrence that occurs at any dose which results in death, is life threatening, requires hospitalization, results in persistent/significant disability/incapacity, is an infection that requires parenteral antibiotics, is a congenital anomaly/birth defect, or is an important medical event.

Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.

Posted

Number

percentage of subjects

From study start to the end of the Safety Follow-up Period (up to 272 weeks)

ID	Title	Description
OG000	Certolizumab Pegol	Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects Achieving Harvey Bradshaw Index (HBI) Remission (HBI ≤ 4) at Study Completion Visit (Week 262)

HBI remission is defined as total HBI score of 4 points or less. HBI score consists of clinical parameters of general well-being (0 to 4), abdominal pain (0 to 3), number of liquid stools per day, abdominal mass (0 to 3), and complications (8 items, score 1 per item) lower scores indicating better well being. The first three parameters are scored for the previous day.

Intention-to-Treat (ITT) population including all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.

Posted

Number

95% Confidence Interval

percentage of subjects

Week 262

ID	Title	Description
OG000	Certolizumab Pegol (Intention-to-Treat)	Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks. The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.

Units	Counts
Participants

Secondary

Percentage of Subjects Achieving Inflamatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170) at Study Completion Visit (Week 262)

IBDQ remission is defined as having a total IBDQ score of 170 points or greater. IBDQ score consists of 32 questions eaching having a score of 1 to 7. Overall scores range from 32 to 224.

Posted

Number

95% Confidence Interval

percentage of subjects

Week 262

ID	Title	Description
OG000	Certolizumab Pegol (Intention-to-Treat)	Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks. The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection.

Units	Counts
Participants	OG000

Secondary

Plasma Concentration of Certolizumab Pegol After 1 Year (Week 52)

Plasma samples for determination of Certolizumab Pegol were taken prior to Certolizumab Pegol administration.

Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.

Posted

Geometric Mean

95% Confidence Interval

μg/mL

Week 52

ID	Title	Description
OG000	Certolizumab Pegol	Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects With Positive Anti-CZP Anti-body Status at Any Time From Week 0 of the Feeder Study C87085 to the Study Completion Visit in C87088

Subjects are counted as antibody positive to Certolizumab Pegol if they have at least one positive result from Week 0 in the previous study C87085 [NCT00552058] to the Last Visit in this study. A positive result is defined as Anti-CZP antibody levels > 2.4 units/mL.

Safety Population including all enrolled subjects who received at least 1 open-label injection of study medication.

Posted

Number

percentage of subjects

From Week 0 of study C87085 [NCT00552058] to Study Completion Visit (Week 262) of C87088 (up to 268 weeks)

ID	Title	Description
OG000	Certolizumab Pegol	Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 events3 affected402 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Atrial flutter	Cardiac disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Goitre	Endocrine disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Cataract	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Retinal artery occlusion	Eye disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0006 events6 affected402 at risk
Anal fistula	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 events2 affected402 at risk
Anorectal disorder	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Colon dysplasia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00059 events51 affected402 at risk
Enteritis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Enterocolonic fistula	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events1 affected402 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Gastrointestinal mucosal disorder	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Ileal fistula	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Ileal stenosis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Ileus	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Intestinal fistula	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00011 events11 affected402 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Intestinal stenosis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Large intestinal ulcer	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Oesophageal perforation	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Proctitis	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0006 events6 affected402 at risk
Subileus	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Chest pain	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Incarcerated hernia	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Mass	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events1 affected402 at risk
Pyrexia	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Unevaluable event	General disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Hepatic necrosis	Hepatobiliary disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Abdominal abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0004 events4 affected402 at risk
Abdominal sepsis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Abdominal wall abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Anal abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Appendicitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Dengue fever	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Diverticulitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Ear infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 events1 affected402 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Infectious mononucleosis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Mastoiditis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Otitis externa	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Perirectal abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pharyngitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Psoas abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pyelonephritis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Sepsis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Septic shock	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Subdiaphragmatic abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0005 events5 affected402 at risk
Vulval abscess	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Abdominal wound dehiscence	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Anastomotic haemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Intestinal anastomosis complication	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Post procedural inflammation	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Transfusion-related acute lung injury	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Colonoscopy	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Investigation	Investigations	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Fistula	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0004 events4 affected402 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Brain oedema	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Convulsion	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Demyelination	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Migraine	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Sciatica	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0005 events1 affected402 at risk
Syncope	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pregnancy on contraceptive	Pregnancy, puerperium and perinatal conditions	MedDRA 17.1	Non-systematic Assessment	EG0005 events5 affected402 at risk
Acute psychosis	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Depression	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0003 events3 affected402 at risk
Depression suicidal	Psychiatric disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0005 events5 affected402 at risk
Renal colic	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA 17.1	Non-systematic Assessment	EG0002 events2 affected402 at risk
Menstrual disorder	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pelvic prolapse	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Vaginal inflammation	Reproductive system and breast disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Pulmonary vasculitis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Physical assault	Social circumstances	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Social stay hospitalisation	Social circumstances	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Victim of abuse	Social circumstances	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Arteritis	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Hypotension	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Varicose vein	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk
Venous thrombosis	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG0001 events1 affected402 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 17.1	Non-systematic Assessment	EG00045 events34 affected402 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG000191 events127 affected402 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG000122 events75 affected402 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00093 events61 affected402 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00063 events46 affected402 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00060 events43 affected402 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00037 events32 affected402 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00028 events24 affected402 at risk
Pyrexia	General disorders	MedDRA 17.1	Non-systematic Assessment	EG000106 events54 affected402 at risk
Influenza like illness	General disorders	MedDRA 17.1	Non-systematic Assessment	EG00040 events23 affected402 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG00099 events63 affected402 at risk
Nasopharyngitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG00088 events46 affected402 at risk
Influenza	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG00035 events30 affected402 at risk
Sinusitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG00048 events29 affected402 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG00031 events25 affected402 at risk
Bronchitis	Infections and infestations	MedDRA 17.1	Non-systematic Assessment	EG00032 events21 affected402 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG00079 events57 affected402 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG00040 events36 affected402 at risk
Headache	Nervous system disorders	MedDRA 17.1	Non-systematic Assessment	EG00058 events45 affected402 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00049 events39 affected402 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Non-systematic Assessment	EG00027 events23 affected402 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 17.1	Non-systematic Assessment	EG00039 events27 affected402 at risk
Hypertension	Vascular disorders	MedDRA 17.1	Non-systematic Assessment	EG00030 events28 affected402 at risk

Ancestor Terms

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments
D007128	Immunoglobulin Fragments
D010446	Peptide Fragments
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D012712	Serum Globulins
D005916	Globulins

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