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 @ 11:14 PM
Ignite Modification Date: 2025-12-25 @ 8:50 PM
NCT ID: NCT03187769
Description: None
Frequency Threshold: 2
Time Frame: 16 Weeks
Study: NCT03187769
Study Brief: Study to Evaluate the Efficacy of ALKS 3831 on Body Weight in Young Adults Who Have Been Recently Diagnosed With Schizophrenia, Schizophreniform, or Bipolar I Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ALKS 3831 Coated bilayer tablet ALKS 3831: Olanzapine + samidorphan, daily oral dosing 1 None 8 211 134 211 View
Olanzapine Coated bilayer tablet Olanzapine: Daily oral dosing 0 None 8 215 136 215 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Toxicity to various agents NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Varicella NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Limb deformity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Bipolar I Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Waist Circumference Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View