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 @ 7:38 PM
Ignite Modification Date: 2025-12-25 @ 5:18 PM
NCT ID: NCT04524403
Description: The Safety Population was patients who received ≥1 dose of study drug.
Frequency Threshold: 5
Time Frame: Baseline Day 1 to Week 30
Study: NCT04524403
Study Brief: A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Miricorlilant 600 mg Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 600 mg (4 X 150 mg) tablets for once-daily oral dosing 0 None 1 50 8 50 View
Miricorlilant 900 mg Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks. Miricorlilant: Miricorilant 900 mg (6 X 150 mg) tablets for once-daily oral dosing 0 None 2 48 3 48 View
Placebo Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks. Placebo: Placebo for once-daily oral dosing 0 None 2 52 4 52 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Regressive behavior SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pulmonary mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View