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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT00281320
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00281320
Study Brief: Study of Asenapine in Elderly Subjects With Psychosis (A7501021)(P05717)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Asenapine 2-10mg BID None None None 6 61 21 61 View
Asenapine 5-10mg BID None None None 3 61 21 61 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders 10.1 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders 10.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 10.1 View
Metastases to pleura SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10.1 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders 10.1 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders 10.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders 10.1 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders 10.1 View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders 10.1 View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders 10.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Asthenia SYSTEMATIC_ASSESSMENT General disorders 10.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations 10.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations 10.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders 10.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 10.1 View
Parkinsonism SYSTEMATIC_ASSESSMENT Nervous system disorders 10.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders 10.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders 10.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders 10.1 View