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: 2025-12-24 @ 1:48 PM
Ignite Modification Date: 2025-12-25 @ 12:41 PM
NCT ID: NCT02806895
Description: The Safety Population consisted of all subjects who received at least 1 dose of study medication. If a subject experienced more than 1 of a given adverse event (AE), the subject is counted only once for that AE.
Frequency Threshold: 5
Time Frame: Adverse events were reported from the time written informed consent was obtained until the final study visit or early termination, up to 21 days.
Study: NCT02806895
Study Brief: Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in OSA
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Subjects received a single oral daily dose of placebo for 7 days in treatment period 1 or treatment period 2 in a counterbalanced order. 0 None 0 33 8 33 View
JZP-110 Subjects received a single oral daily dose of JZP-110 (150 mg/day for 3 days) then JZP-110 (300 mg/day for 4 days) in treatment period 1 or treatment period 2 in a counterbalanced order. 0 None 0 34 15 34 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.0 View