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: 2025-12-26 @ 10:57 AM
Ignite Modification Date: 2025-12-26 @ 10:57 AM
NCT ID: NCT02873208
Description: None
Frequency Threshold: 2
Time Frame: 52 weeks
Study: NCT02873208
Study Brief: A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
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 All subjects assigned to ALKS 3831 in ALKS 3831-A303 and ALKS 3831-A304 ALKS 3831: Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan Oral tablet, daily dosing 0 None 5 265 103 265 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastritis alcoholic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Schizophrenia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychotic disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Toothache NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Extra dose administered NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Weight decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Weight increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Blood creatine phosphokinase increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View