Adverse Events Module

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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: 2025-12-25 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:22 AM
NCT ID: NCT01199302
Description: None
Frequency Threshold: 4
Time Frame: From first dose of study drug until the end of study; median (min, max) duration was 70 days (14, 223)
Study: NCT01199302
Study Brief: Long-term Safety Study of Brodalumab in Adults With 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
Brodalumab 350 mg Q4W Participants received brodalumab 350 mg IV Q4W for up to 132 weeks. None None 15 67 36 67 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Anal stenosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Intestinal dilatation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Peritoneal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 14.1 View
Cutaneous vasculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Crohn's disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Oral candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Abdominal tenderness SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View