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: 2025-12-25 @ 4:53 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT02161718
Description: None
Frequency Threshold: 5
Time Frame: Adverse events are presented for the randomized, double-blind period (9-15 months) as well as the 2 week open-label ALKS 3831 (olanzapine + samidorphan) period for a total timeframe of up to 62 weeks.
Study: NCT02161718
Study Brief: A Study of ALKS 3831 in Subjects With Schizophrenia and Alcohol Use 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
Open- Label ALKS 3831 A 2-week open-label period; all subjects received olanzapine (dose determined by investigator) + 10 mg samidorphan 0 None 4 255 0 255 View
Olanzapine + Placebo All randomized subjects who received at least 1 dose of study drug (olanzapine + placebo) during the double-blind treatment period 1 None 12 117 19 117 View
ALKS 3831 All randomized subjects who received at least 1 dose of ALKS 3831 (olanzapine + samidorphan) during the double-blind treatment period. 1 None 7 112 26 112 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Parotitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Disturbance in social behavior NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Alcoholism NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Schizophrenia, paranoid type NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Paranoia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Alcohol poisoning NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Laceration NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Electrocardiogram abnormal NON_SYSTEMATIC_ASSESSMENT Investigations None View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Aggression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View