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 @ 5:57 PM
Ignite Modification Date: 2025-12-25 @ 3:20 PM
NCT ID: NCT02227368
Description: Only SAEs and AEs of interest were collected for this study. Treatment Emergent SAEs and Treatment Emergent AEs of interest are reported here.
Frequency Threshold: 0
Time Frame: 26 weeks treatment period + 30 days followup
Study: NCT02227368
Study Brief: Walking Effect of Long Term Ticagrelor in Subjects With PAD Who Have Undergone EVR
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ticagrelor Ticagrelor 90mg twice a day plus aspirin placebo once daily None None 4 16 1 16 View
Aspirin Aspirin 100mg once daily plus ticagrelor placebo twice a day None None 2 24 1 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 17.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 17.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 17.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 17.0 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 17.0 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 17.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 17.0 View
Peripheral artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 17.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 17.0 View
Arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 17.0 View