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 @ 6:54 PM
Ignite Modification Date: 2025-12-25 @ 4:27 PM
NCT ID: NCT03201757
Description: None
Frequency Threshold: 2
Time Frame: Adverse events were collected throughout the treatment period (24- 48 months) and through-out the safety follow-up period (4 weeks);
Study: NCT03201757
Study Brief: Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
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 35 523 314 523 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Iron deficiency anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Aortic valve incompetence NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pericardial haemorrhage NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Crohn's disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastric Ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Haematochezia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Mallory-Weiss syndrome NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Obstructive pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Anaphylactic shock NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Large intestine infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Accidental overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Craniocerebral injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skull fractured base NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thoracic vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic haemothorax NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic intracranial haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Traumatic liver injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vena cava injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Blood urine present NON_SYSTEMATIC_ASSESSMENT Investigations None View
Infected naevus NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Drug withdrawal convulsions NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Intracranial aneursym NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute psychosis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Aggression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Completed suicide NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression Suicidal NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Mania NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychiatric symptom NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychotic symptom NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Substance-induced psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicide attempt NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Blood prolactin increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Blood triglycerides increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Low density lipoprotein increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View