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 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:56 PM
NCT ID: NCT02522767
Description: TEAEs were defined as AE which occurred in the time interval from initial dosing (IMP intake) to the end of treatment visit.
Frequency Threshold: 2
Time Frame: TEAE occurred in the time interval from initial dosing (IMP intake) to the end of trial visit, up to 8 weeks for the Mesalamine and Placebo Arms and an additional 8 weeks for the Open-Label extension period.
Study: NCT02522767
Study Brief: Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)
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 Placebo 4 g to match mesalamine extended release granules, administered orally QD 0 None 0 114 13 114 View
Mesalamine Mesalamine 4 g extended release granules (sachet), administered orally QD 0 None 1 114 19 114 View
Mesalamine (Open-Label) Mesalamine 4 g extended release granules (sachet), administered orally QD 0 None 2 170 8 170 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Spondylitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (21.0) View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Faecal calprotectin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (21.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Colitis ulcerative SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View