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 @ 7:17 PM
Ignite Modification Date: 2025-12-25 @ 4:55 PM
NCT ID: NCT03037203
Description: The Safety population includes all subjects who received at least one dose of study drug
Frequency Threshold: 5
Time Frame: Up to Day 35
Study: NCT03037203
Study Brief: A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive 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
JZP-110 300 mg The JZP-110 300 mg group consists of all subjects in the Safety population who also received at least 1 dose of 300 mg from Sequences A (28) and B (26), with a total of 54 subjects. 0 None 1 54 4 54 View
JZP-110 75 mg The JZP-110 75 mg group consists of all subjects in the Safety population who also received at least 1 dose of 75 mg from Sequences A (28) and B (28), with a total of 56 subjects. 0 None 0 56 4 56 View
JZP-110 150 mg The JZP-110 150 mg group consists of all subjects in the Safety population who also received at least 1 dose of 150 mg from Sequences A (28) and B (27), with a total of 55 subjects. 0 None 0 55 5 55 View
Placebo The Placebo group consists of all subjects in the Safety population who also received at least 1 dose of Placebo from Sequences A (28), B (26), and C (10) with a total of 64 subjects. 0 None 0 64 0 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (18.0) View
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