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 @ 2:20 AM
Ignite Modification Date: 2025-12-26 @ 12:52 AM
NCT ID: NCT04803734
Description: The population for safety evaluation was defined as all subjects who took at least one of study drugs. Only AE occurs after first dosing will be analyzed for safety assessment.
Frequency Threshold: 0
Time Frame: Approximately 16 days for each subject.
Study: NCT04803734
Study Brief: Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg Per Actuation in Healthy Volunteers Under Fasting Conditions
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Group Albuterol Sulfate inhalation aerosol 108 mcg per actuation: MDI, 2 puffs, single dose, fasting 0 None 0 60 4 60 View
Reference Group Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation: MDI, 2 puffs, single dose, fasting 0 None 0 58 1 58 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Throat infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Aspartate aminotransferase (AST) increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Alanine aminotransferase (ALT) increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hypertriglyceridemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View