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 @ 1:36 PM
Ignite Modification Date: 2025-12-24 @ 1:36 PM
NCT ID: NCT01132495
Description: Only Serious Adverse Events were collected in this study.
Frequency Threshold: 0
Time Frame: Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Study: NCT01132495
Study Brief: FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cohort A - PCI Plus OMT PCI plus optimal medical treatment Stenting plus OMT: FFR guided PCI, plus OMT None None 137 447 0 0 View
Cohort A - OMT Alone Optimal medical treatment alone Standard of care: OMT alone None None 324 441 0 0 View
Cohort B - Follow-up Observation with treatment based on physician preference None None 55 166 0 0 View
Cohort B - No Follow-up Re-consented Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data None None 28 116 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non Urgent Revacularization NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Death or MI NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Unplanned Hospitalization with Urgent Revascularization NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cerebrovascular Event NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other SAE NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):