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 @ 4:14 AM
Ignite Modification Date: 2025-12-26 @ 3:13 AM
NCT ID: NCT03624920
Description: Listing of AEs reported are corresponding to TEAEs (treatment emergent adverse event) collected from randomization to last visit
Frequency Threshold: 2
Time Frame: AE collection through study duration, starts with screening until follow up visit (last phone call), a total of 13 weeks.
Study: NCT03624920
Study Brief: Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
THN102 Placebo THN102 Placebo (Dosage A) 0 None 0 68 3 68 View
THN102 200/2 THN102 200 mg/2 mg (Dosage B) 0 None 0 72 10 72 View
THN102 200/18 THN102 200 mg/18 mg (Dosage C) 0 None 1 73 22 73 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
CONTUSION SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (21.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (21.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Nightmare SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (21.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (21.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (21.0) View
Muscle spasm SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (21.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (21.0) View