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 @ 2:23 PM
Ignite Modification Date: 2025-12-25 @ 12:59 PM
NCT ID: NCT01754259
Description: The definition of adverse events and serious adverse events are the same as the clinicaltrials.gov definitions.
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of informed consent through the telephone follow-up on Day 74.
Study: NCT01754259
Study Brief: Effects of Ranolazine on Coronary Flow Reserve in Symptomatic Diabetic Patients and CAD
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 subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor. Ranolazine: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor. 0 None 0 23 12 23 View
Placebo Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor. Placebo Pill: Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor. 0 None 1 24 2 24 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall complicated by non-fatal intracerebral hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypoglycemia SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Renal abnormality SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Transaminitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nausea and Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest pain requiring evaluation SYSTEMATIC_ASSESSMENT Cardiac disorders None View