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 @ 1:17 AM
Ignite Modification Date: 2025-12-25 @ 11:25 PM
NCT ID: NCT03579693
Description: Definitions used were consistent with clinicaltrials.gov. At each visit potential adverse events were assessed by participant interview.
Frequency Threshold: 5
Time Frame: For each treatment arm, adverse events are reported from the start of the treatment until the next visit (approximately 6 weeks total for each treatment).
Study: NCT03579693
Study Brief: Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CoQ10 Coenzyme Q10, 2 - 250 mg tablets twice a day (1000 mg total daily dose) for 6 weeks 0 None 0 25 0 25 View
Nicotinamide Riboside Nicotinamide riboside, 1 - 600 mg tablet twice a day (1200 mg total daily dose) for 6 weeks 0 None 0 25 1 25 View
Placebo Placebo, inactive sugar pill for 6 weeks 0 None 0 25 2 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory illness SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View