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 @ 11:53 PM
Ignite Modification Date: 2025-12-25 @ 9:48 PM
NCT ID: NCT04068051
Description: Safety Population includes all subjects who received at least one dose of study drug.
Frequency Threshold: 3
Time Frame: Adverse events were collected after administration of study drug through the final visit (up to 12 months). Any AE was monitored up to a maximum of 30 days after the final visit.
Study: NCT04068051
Study Brief: Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
AXS-07 AXS-07 (MoSEIC™ meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine. 0 None 8 706 95 706 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Mitral valve incompetence NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Dictionary View
Hiatus hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Dictionary View
Hepatitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Dictionary View
Burns third degree NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Dictionary View
Musculoskeletal procedural complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Dicionary View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Dictionary View
Endometrial hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Dictionary View
Victim of crime NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA Dictionary View
Skin graft NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA Dictionary View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Dictionary View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Dictionary View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Dictionary View