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: NCT03823703
Description: The analysis population included all patients who received at least 1 dose of study medication.
Frequency Threshold: 5
Time Frame: Up to ~Day 95 for all cause mortality, serious adverse events and other non-serious treatment-emergent adverse events (TEAEs) during the study period.
Study: NCT03823703
Study Brief: Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
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 Participants received 6 placebo tablets orally once daily. 0 None 0 4 1 4 View
Miricorilant- 900 mg Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily. 0 None 2 3 3 3 View
Miricorilant- 600 mg Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily. 0 None 0 5 5 5 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Drug-induced liver injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 23.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 23.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 23.0 View
Influenza like illness SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Malaise SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 23.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 23.0 View
Muscle rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 23.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Electrocardiogram abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 23.0 View