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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
NCT ID: NCT01648205
Description: None
Frequency Threshold: 5
Time Frame: Adverse events data were collected for 1 month on placebo and for up to 5 months on ranolazine.
Study: NCT01648205
Study Brief: Long-term Efficacy Study of Sodium Channel Blocker in LQT3 Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ranolazine During 5 months on ranolazine following adverse events were reported: Ventricular fibrillation successfully treated with shock from implantable cardioverter-defibrillator (n=1) Ventricular fibrillation unsuccessfully treated with shock from implantable cardioverter-defibrillator with subsequent death (n=1) Bundle branch block (n=1) Dizziness/unsteadiness (n=3) Headache (n=1) Constipation (n=1) Hematuria (n=1) Hemorrhoids (n=1) 1 None 2 25 3 25 View
Placebo During 1 month on placebo following adverse events were reported: Pregnancy (n=1) Gastritis (n=1) Generalized weakness (n=1) 0 None 0 25 0 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ventricular Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View