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 @ 2:34 AM
Ignite Modification Date: 2025-12-26 @ 1:11 AM
NCT ID: NCT02357134
Description: In this protocol, the Adverse events were not measured as an absolute number. It was measured as a numeric rating score from 0 (not at all) to 10 (worst possible). So there are no Adverse events numbers in the Adverse Events section. As per the protocol, Adverse events were considered as a secondary outcome. Please see 'Adverse Events' under 'Outcome Measure.'
Frequency Threshold: 5
Time Frame: before and after 3rd test during intervention phase, approximately up to 12 minutes
Study: NCT02357134
Study Brief: High-Flow Oxygen in Reducing Shortness of Breath Caused by Exercise in Patients With Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
High Flow Air High Flow Air were delivered between 20 and 70 L/min 0 None 0 0 0 0 View
Low Flow Oxygen Low Flow Oxygen were delivered at 2 L/min 0 None 0 0 0 0 View
Low Flow Air Low Flow Air were delivered at 2 L/min 0 None 0 0 0 0 View
High Flow Oxygen High Flow Oxygen were delivered between 20 and 70 L/min 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):