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 @ 12:38 AM
Ignite Modification Date: 2025-12-25 @ 10:49 PM
NCT ID: NCT05003167
Description: No changes to definitions of adverse events. Participants rated breathlessness on a scale of 0-10 (no breathlessness to completed breathlessness) before and after estimating maximum expiratory pressure and the EMST training protocol. Participants were also interviewed weekly about issues with at home training and were observed in training once a week.
Frequency Threshold: 0
Time Frame: Over the course of the study (10 weeks for each participant)
Study: NCT05003167
Study Brief: Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Expiratory Muscle Strength Training All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure). Expiratory Muscle Strength Training (EMST-150): All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure). 0 None 0 13 0 13 View
Serious Events(If Any):
Other Events(If Any):