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: 2025-12-24 @ 11:39 PM
Ignite Modification Date: 2025-12-25 @ 9:29 PM
NCT ID: NCT03834051
Description: Adverse event (AE) data were collected from the time of enrollment to 1 year following the initial FMT for participants with ulcerative colitis and irritable bowel syndrome. \*AE data were collected from the time of enrollment to 1 year following the initial FMT for 1 participant each in the Crohn's disease and microscopic colitis groups; AE data were collected from the time of enrollment to 4 weeks following initial FMT from 2 participants from these 2 groups
Frequency Threshold: 5
Time Frame: Ulcerative colitis and irritable bowel syndrome 1 year. Crohn's disease 4 weeks (2 participants) to 1 year (1 participant). Microscopic colitis 4 weeks (2 participants) to 1 year (1 participant)
Study: NCT03834051
Study Brief: Fecal Microbiota Transplantation for Treatment of Gastrointestinal Dysbiosis or Clearance of ARO
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ulcerative Colitis Ulcerative colitis and adverse events Fecal Microbiota Transplantation: Fecal Microbiota Transplantation Rectal Administration Open Label 0 None 1 11 3 11 View
Irritable Bowel Syndrome Irritable bowel syndrome and adverse events 0 None 0 16 0 16 View
Crohn's Disease Crohn's Disease and adverse events 0 None 0 3 0 3 View
Microscopic Colitis Microscopic Colitis and adverse events 0 None 0 3 0 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colitis - colectomy NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
chronic appendicitis - appendectomy NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View