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 @ 10:22 PM
Ignite Modification Date: 2025-12-25 @ 7:54 PM
NCT ID: NCT04776135
Description: This study was designed as a 2-group, 2-period crossover study with the advance administration of edaravone orally group (Oral =\> NGT) with 18 subjects, and the advance administration of edaravone via NGT group (NGT =\> Oral) with 18 subjects to investigate the bioavailability between edaravone orally and via NGT.
Frequency Threshold: 0
Time Frame: The provision of informed consent to Day 11
Study: NCT04776135
Study Brief: Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MT-1186 Orally Healthy subjects were administered a single dose of Edaravone oral suspension (105 mg) orally under fasted condition. 0 None 0 36 1 36 View
MT-1186 Via NGT Healthy subjects were administered a single dose of Edaravone oral suspension (105 mg) via NGT under fasted condition. 0 None 0 36 3 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
Blood creatine phosphokinase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.1 View