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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:28 AM
NCT ID: NCT01115933
Description: None
Frequency Threshold: 5
Time Frame: Nine (9) month post procedure data which includes events which occurred up to 298 days.
Study: NCT01115933
Study Brief: A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese 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
AVJ-09-385 SV EECSS SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System AVJ-09-385 EECSS : Patients receiving AVJ-09-385 EECSS None None 10 64 4 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina unstable SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0) View
Coronary artery restenosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.0) View
None SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (11.0) View
None SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View
None SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
hordeolum, influenza, nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0) View