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 @ 4:32 PM
Ignite Modification Date: 2025-12-25 @ 2:24 PM
NCT ID: NCT01104766
Description: Data is for the Double-blinding treatment period
Frequency Threshold: 5
Time Frame: Assessed over 2 months
Study: NCT01104766
Study Brief: Safety and Efficacy of Cariprazine in Patients 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
Placebo Oral administration. Once per day. 0 None 2 153 68 153 View
Cariprazine 3.0 mg Oral administration. Once per day. 0 None 4 155 61 155 View
Cariprazine 6.0mg Oral administration. Once per day. 2 None 7 157 71 157 View
Aripiprazole 10.0 mg Oral administration. Once per day. 0 None 4 152 61 152 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Schizophrenia, paranoid type SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Complete Suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Dehydration SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.1 View
Ischemic stroke SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Social stay hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.1 View
Transient ischemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 14.1 View
Artropod bite NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Toxicity to various agents SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Schizophrenia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Abdominal discomfort NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Vaginal Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Akathisia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View