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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:17 PM
NCT ID: NCT03178669
Description: None
Frequency Threshold: 5
Time Frame: Adverse Event (AE) was collected from the date of signed informed consent. During the screening period up to first treatment only AEs related to a study specific procedures should be reported. AEs were reported up to follow up visit at Week 10 (from first treatment)
Study: NCT03178669
Study Brief: The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cobitolimod Dose 2x250 mg Dose 250 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration 0 None 4 42 8 42 View
Cobitolimod Dose 2x31 mg Dose 31 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration 0 None 2 40 5 40 View
Cobitolimod Dose 2x125 mg Dose 125 mg of cobitolimod at 2 occasions, placebo at 2 occasions cobitolimod: Rectal administration 0 None 0 43 12 43 View
Cobitolimod Dose 4x125 mg Dose 125 mg of cobitolimod, at 4 occasions cobitolimod: Rectal administration 0 None 2 42 10 42 View
Placebo Placebo at four occasions Placebo: Solution manufactured to mimic cobitolimod 1 None 2 44 11 44 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ulcerative colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Abdominal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Wound Dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (20.0) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (20.0) View
Rash erythematous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (20.0) View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (20.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ulcerative colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.0) View
Viral upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.0) View
Faecal calprotectin increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (20.0) View