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 @ 12:05 PM
Ignite Modification Date: 2025-12-25 @ 11:58 AM
NCT ID: NCT02754661
Description: Adverse events have been collected at the start of the CCE/CTC bowel preparation up until colonoscopy Follow-up call. The following AEs and serious adverse events (SAEs) were collected: * All adverse events related to the CCE, CTC and or OC procedures * All retained capsules greater than 14 days * All perforations * All device deficiencies that may lead to a SAE * All adverse events that meet serious adverse event definition * All deaths
Frequency Threshold: 0
Time Frame: Adverse event data was collected over a 5-6 week period
Study: NCT02754661
Study Brief: Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
COLON Capsule Endoscopy Subjects who had colon capsule endoscopy followed by optical colonoscopy within 5-6 weeks. 0 None 2 145 4 145 View
Computed Tomographic Colonography Subjects who had Computed Tomographic Colonography followed by optical colonoscopy within 5-6 weeks. 0 None 1 141 8 141 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Rectal Haemorrage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Post procedural haemorrahage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chalazion NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 10.0 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Anorectal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Haemmorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Hordeolum NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Procedural pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 10.0 View
Blood pressure increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 10.0 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.0 View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.0 View