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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT01698333
Description: The Safety population included all subjects enrolled in the study who were dispensed the test article at least once. Each subject counted once for each AE Term.
Frequency Threshold: 0
Time Frame: AEs were collected from study screening (performed 20 days or more prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
Study: NCT01698333
Study Brief: Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
122-0551 122-0551: Applied twice daily for 2 weeks 0 None 0 25 8 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v15.0 View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA v15.0 View
Procedural Nausea NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v15.0 View
ACTH Stimulation Test Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA v15.0 View
Nasal Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v15.0 View