Examining the Long Term Safety, Efficacy, and Corticoster... | NCT00356408

NCT00356408

ID	Type	Description	Link
2006-003871-11	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions 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
CDP870 400 mg	Experimental	Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2	Biological: Certolizumab pegol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Certolizumab pegol	Biological	Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg). Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)	Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.	During this study (maximum 122 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.	Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.

Eligibility Module

Contacts/Locations Module

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

References Module

Label	URL
FDA Safety Alerts and Recalls	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	CDP870 400 mg	Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG000103 subjects106 subjects enrolled, however only 103 were included in the Intent to Treat (ITT) population.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Placebo/Completer	Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
BG001	CDP870/Completer	CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
BG002	Placebo/Non-completer	Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
BG003	CDP870/Non-completer	CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00044.00± 12.53 BG00139.31± 12.83 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0006 BG0019 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG0008 BG00110 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)

Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.

All subjects in the the Intent to Treat (ITT) population are included in this analysis.

Posted

Number

subjects

During this study (maximum 122 weeks)

ID	Title	Description
OG000	Placebo/Completer	Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
OG001	CDP870/Completer	CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
OG002	Placebo/Non-completer	Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
OG003	CDP870/Non-completer	CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).

Units	Counts
Participants	OG00014 OG00116 OG00240 OG003

Title

Denominators

Categories

Title	Measurements
	OG00012 OG00115 OG00232 OG003

Secondary

Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.

Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.

All subjects in the the Intent to Treat (ITT) population are included in this analysis.

Posted

Number

percentage of subjects

Week 34 in this study

ID	Title	Description
OG000	Placebo/Completer	Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
OG001	CDP870/Completer	CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
OG002	Placebo/Non-completer	Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo/Completer	Placebo Completer: Placebo subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.	5	14	11	14
EG001	CDP870/Completer	CDP870 Completer: CDP870 subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.	0	16	15	16
EG002	Placebo/Non-completer	Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).	6	40	31	40
EG003	CDP870/Non-completer	CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).	4	33	27	33
EG004	CDP870 400 mg (Overall)	Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2	15	103	84	103

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Crohn's Disease	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0026 events3 affected40 at risk EG0031 events1 affected33 at risk EG0048 events5 affected103 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0021 events1 affected40 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0021 events1 affected40 at risk EG003
Intestinal Fistula	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0002 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0002 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Sepsis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Perianal Abscess	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0002 events2 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Bronchopulmonary Aspergillosis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Abscess	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0021 events1 affected40 at risk EG003
Abdominal Abscess	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Anastomotic Leak	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0002 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Gastrointestinal Stoma Complication	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Intentional Overdose	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Failure To Thrive	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Renal Failure	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Renal Failure Acute	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0022 events2 affected40 at risk EG0031 events1 affected33 at risk EG004
Anaemia	Blood and lymphatic system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0023 events3 affected40 at risk EG003
Palpitations	Cardiac disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Ear Pain	Ear and labyrinth disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0023 events2 affected40 at risk EG003
Cerumen Impaction	Ear and labyrinth disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Crohn's Disease	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0012 events2 affected16 at risk EG00211 events8 affected40 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0012 events2 affected16 at risk EG0022 events2 affected40 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0003 events2 affected14 at risk EG0012 events2 affected16 at risk EG0022 events2 affected40 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0024 events4 affected40 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected16 at risk EG00211 events3 affected40 at risk EG003
Abdominal Distension	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0002 events2 affected14 at risk EG0011 events1 affected16 at risk EG0022 events2 affected40 at risk EG003
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0003 events2 affected14 at risk EG0012 events2 affected16 at risk EG0023 events2 affected40 at risk EG003
Abdominal Pain Lower	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0024 events3 affected40 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0022 events2 affected40 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected16 at risk EG0022 events2 affected40 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0022 events1 affected40 at risk EG003
Tooth Impacted	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0022 events2 affected40 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Food Poisoning	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0021 events1 affected40 at risk EG003
Anal Fissure	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0014 events2 affected16 at risk EG0020 events0 affected40 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected16 at risk EG0020 events0 affected40 at risk EG003
Gastrointestinal Hypomotility	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Dental Discomfort	Gastrointestinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Pyrexia	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected16 at risk EG0024 events4 affected40 at risk EG003
Fatigue	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0003 events1 affected14 at risk EG0011 events1 affected16 at risk EG0022 events2 affected40 at risk EG003
Oedema Peripheral	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0022 events2 affected40 at risk EG003
Influenza Like Illness	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0012 events2 affected16 at risk EG0021 events1 affected40 at risk EG003
Chills	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Injection Site Pain	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0012 events1 affected16 at risk EG0023 events2 affected40 at risk EG003
Injection Site Irritation	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0022 events1 affected40 at risk EG003
Injection Site Erythema	General disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0021 events1 affected40 at risk EG003
Seasonal Allergy	Immune system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0021 events1 affected40 at risk EG003
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0012 events2 affected16 at risk EG0027 events6 affected40 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0002 events2 affected14 at risk EG0010 events0 affected16 at risk EG0029 events7 affected40 at risk EG003
Sinusitis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0014 events3 affected16 at risk EG0026 events5 affected40 at risk EG003
Urinary Tract Infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0024 events4 affected40 at risk EG003
Influenza	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected16 at risk EG0027 events4 affected40 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0022 events2 affected40 at risk EG003
Herpes Simplex	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Bronchitis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected16 at risk EG0021 events1 affected40 at risk EG003
Lower Respiratory Tract Infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Chronic Sinusitis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Folliculitis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0014 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Viral Infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Abdominal Abscess	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Onychomycosis	Infections and infestations	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Postoperative Ileus	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Exposure To Toxic Agent	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Meniscus Lesion	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Procedural Pain	Injury, poisoning and procedural complications	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Heart Rate Increased	Investigations	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Blood Creatinine Abnormal	Investigations	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Hepatic Enzyme Abnormal	Investigations	MedDRA (9.0)	Non-systematic Assessment	EG0002 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0021 events1 affected40 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0021 events1 affected40 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0021 events1 affected40 at risk EG003
Anorexia	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0016 events4 affected16 at risk EG00211 events8 affected40 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0014 events3 affected16 at risk EG0023 events3 affected40 at risk EG003
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected16 at risk EG0024 events3 affected40 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0022 events2 affected40 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0021 events1 affected40 at risk EG003
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Shoulder Pain	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Muscle Fatigue	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Headache	Nervous system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0027 events5 affected40 at risk EG003
Dizziness	Nervous system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0024 events4 affected40 at risk EG003
Migraine	Nervous system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected16 at risk EG0023 events2 affected40 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0022 events1 affected40 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Depression	Psychiatric disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0012 events2 affected16 at risk EG0022 events2 affected40 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0022 events2 affected40 at risk EG003
Stress	Psychiatric disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Nervousness	Psychiatric disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Agitation	Psychiatric disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Pharyngolaryngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0024 events4 affected40 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected16 at risk EG0021 events1 affected40 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0022 events2 affected40 at risk EG003
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0021 events1 affected40 at risk EG003
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0022 events1 affected40 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0012 events2 affected16 at risk EG0020 events0 affected40 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0003 events2 affected14 at risk EG0010 events0 affected16 at risk EG0022 events1 affected40 at risk EG003
Erythema Nodosum	Skin and subcutaneous tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0010 events0 affected16 at risk EG0022 events2 affected40 at risk EG003
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0000 events0 affected14 at risk EG0011 events1 affected16 at risk EG0021 events1 affected40 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected16 at risk EG0020 events0 affected40 at risk EG003
Vascular Skin Disorder	Skin and subcutaneous tissue disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0010 events0 affected16 at risk EG0020 events0 affected40 at risk EG003
Hypertension	Vascular disorders	MedDRA (9.0)	Non-systematic Assessment	EG0001 events1 affected14 at risk EG0011 events1 affected16 at risk EG0022 events2 affected40 at risk EG003

ID	Term
D003424	Crohn Disease

ID	Term
D000068582	Certolizumab Pegol

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

EG0044 events3 affected103 at risk

EG0042 events2 affected103 at risk

EG0041 events1 affected103 at risk

EG0042 events1 affected103 at risk

EG0041 events1 affected103 at risk

EG0042 events2 affected103 at risk

EG0041 events1 affected103 at risk

EG0042 events1 affected103 at risk

EG0041 events1 affected103 at risk

EG0044 events4 affected103 at risk

EG0041 events1 affected103 at risk

EG0043 events2 affected103 at risk

EG0041 events1 affected103 at risk

EG00427 events22 affected103 at risk

EG00411 events11 affected103 at risk

EG00411 events9 affected103 at risk

EG0048 events8 affected103 at risk

EG00416 events7 affected103 at risk

EG0046 events6 affected103 at risk

EG0048 events6 affected103 at risk

EG0047 events5 affected103 at risk

EG0046 events5 affected103 at risk

EG0044 events4 affected103 at risk

EG0044 events3 affected103 at risk

EG0043 events3 affected103 at risk

EG0042 events2 affected103 at risk

EG0044 events2 affected103 at risk

EG0042 events2 affected103 at risk

EG0041 events1 affected103 at risk

EG0049 events8 affected103 at risk

EG0048 events6 affected103 at risk

EG0044 events4 affected103 at risk

EG0043 events3 affected103 at risk

EG0045 events3 affected103 at risk

EG0043 events2 affected103 at risk

EG0042 events2 affected103 at risk

EG0043 events3 affected103 at risk

EG00417 events14 affected103 at risk

EG00415 events12 affected103 at risk

EG00412 events10 affected103 at risk

EG0049 events8 affected103 at risk

EG00410 events7 affected103 at risk

EG0044 events4 affected103 at risk

EG0043 events3 affected103 at risk

EG0042 events2 affected103 at risk

EG0041 events1 affected103 at risk

EG0044 events1 affected103 at risk

EG0041 events1 affected103 at risk

EG0042 events2 affected103 at risk

EG0041 events1 affected103 at risk

EG0042 events1 affected103 at risk

EG0043 events3 affected103 at risk

EG0042 events2 affected103 at risk

EG0041 events1 affected103 at risk

EG00425 events19 affected103 at risk

EG0048 events7 affected103 at risk

EG0046 events5 affected103 at risk

EG0046 events3 affected103 at risk

EG0042 events2 affected103 at risk

EG0041 events1 affected103 at risk

EG0042 events2 affected103 at risk

EG00414 events11 affected103 at risk

EG0047 events7 affected103 at risk

EG00417 events6 affected103 at risk

EG0043 events2 affected103 at risk

EG0041 events1 affected103 at risk

EG0046 events6 affected103 at risk

EG0044 events4 affected103 at risk

EG0043 events3 affected103 at risk

EG0041 events1 affected103 at risk

EG0046 events6 affected103 at risk

EG0043 events3 affected103 at risk

EG0042 events2 affected103 at risk

EG0043 events2 affected103 at risk

EG0042 events2 affected103 at risk

EG0049 events6 affected103 at risk

EG0042 events2 affected103 at risk

EG0041 events1 affected103 at risk

EG0046 events6 affected103 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

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