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 @ 5:54 PM
Ignite Modification Date: 2025-12-25 @ 3:18 PM
NCT ID: NCT03241368
Description: None
Frequency Threshold: 0
Time Frame: 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Study: NCT03241368
Study Brief: Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal 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
MRE, Patency Capsule (if Needed), CE, and IC Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure. Capsule Endoscopy: At baseline subject will under the PillCam Crohn's Capsule Procedure 0 None 7 119 11 119 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ISO 14155:2011 View
Crohn's Disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ISO 14155:2011 View
Complication of device removal NON_SYSTEMATIC_ASSESSMENT General disorders ISO 14155:2011 View
Clostridium difficile infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations ISO 14155:2011 View
Serum sickness NON_SYSTEMATIC_ASSESSMENT Immune system disorders ISO 14155:2011 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ISO 14155:2011 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ISO 14155:2011 View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ISO 14155:2011 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ISO 14155:2011 View
Infusion site extravasation NON_SYSTEMATIC_ASSESSMENT General disorders ISO 14155:2011 View
Oesophageal candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations ISO 14155:2011 View
Staphylococcal skin infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations ISO 14155:2011 View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ISO 14155:2011 View
Post procedural complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ISO 14155:2011 View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations ISO 14155:2011 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ISO 14155:2011 View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders ISO 14155:2011 View
Emotional distress NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders ISO 14155:2011 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders ISO 14155:2011 View