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 @ 7:48 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT03249103
Description: Adverse Events were collected and are summarized for all NYX-2925 exposure. Adverse events were not collected with regard to specific dose.
Frequency Threshold: 5
Time Frame: Adverse events were collected from the time the informed consent was signed to the end of the subject's participation in the study (Week 7).
Study: NCT03249103
Study Brief: Evaluate the Efficacy and Safety of NYX-2925 in Subjects With Fibromyalgia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
All Treated Subjects Subjects received Placebo, 20 mg NYX-2925 QD, and 200 mg NYX-2925 QD. Adverse Events were collected and are summarized for all NYX-2925 exposure. Adverse events were not collected with regard to specific dose. 0 None 0 22 7 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhoea/ SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Tension headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View