Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 5:57 PM
Ignite Modification Date: 2025-12-25 @ 3:20 PM
NCT ID: NCT00291668
Description: Adverse Events refer to the Safety Population, including all randomized subjects who received at least one dose of study medication (Placebo or Certolizumab Pegol).
Frequency Threshold: 5
Time Frame: Adverse Events were collected from the time of signing the informed consent through the last Observation (up to 28 weeks).
Study: NCT00291668
Study Brief: Clinical Study of CDP870/Certolizumab Pegol in Patients With Active Crohn's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Subjects received two subcutaneous (sc) injections of Placebo on Weeks 0 (first dose), 2 and 4. 0 None 3 32 16 32 View
Certolizumab Pegol 200 mg Subjects received one subcutaneous (sc) injection of 200 mg CZP and one injection of Placebo to maintain the study blind on Weeks 0 (first dose), 2 and 4. 0 None 1 30 11 30 View
Certolizumab Pegol 400 mg Subjects received two subcutaneous (sc) injections of 200 mg CZP on Weeks 0 (first dose), 2 and 4. 0 None 3 32 14 32 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Disseminated intravascular coagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA9.0 View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA9.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA9.0 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA9.0 View
Peritonitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA9.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA9.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA9.0 View
Pneumonia aspiration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA9.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA9.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA9.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA9.0 View
Hepatic function abnormal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA9.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA9.0 View
White blood cell count decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA9.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA9.0 View
Pharyngolaryngeal pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA9.0 View
Pharynx discomfort NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA9.0 View
Upper respiratory tract inflammation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA9.0 View
Comedone NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA9.0 View