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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT03101904
Description: None
Frequency Threshold: 0
Time Frame: Adverse even data was collected throughout participant involvement in the study. Adverse even data was collected 2 hours and 48 hours after each laboratory visit.
Study: NCT03101904
Study Brief: The Effect of Chronic Nitrate Supplementation on Acute Mountain Sickness and Exercise Performance in Hypoxia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nitrate Participants consumed a daily a beetroot shot for six days. Each shot will consist of: 1x70ml concentrated NO-3 shot of rich Beetroot juice (\~7mmol nitrate; Beet It, James White Drinks Ltd, Ipswich, UK). 0 None 0 23 1 23 View
Placebo Participants consumed a daily Nitrate-depleted beetroot shot for six days. Each shot will consist of 1x70ml nitrate-depleted beetroot Placebo shot (\~0.003mmol of nitrate; Beet It, James White Drinks Ltd, Ipswich, UK). 0 None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Chest Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View