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 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT00665366
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00665366
Study Brief: Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I 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
Aripiprazole None None None 11 180 45 180 View
Placebo None None None 17 189 29 189 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Grand mal convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Psychotic disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Alcohol abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Spinal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Vertebrobasilar insufficiency SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Bipolar I disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Depression suicidal SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 14.1 View
Intentional drug misuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View