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 @ 5:48 PM
Ignite Modification Date: 2025-12-25 @ 3:15 PM
NCT ID: NCT01058668
Description: Safety Population included all participants who received at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: First dose of study drug to 30 days past last dose (Up to 51 days)
Study: NCT01058668
Study Brief: Safety and Efficacy of Cariprazine for 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
Cariprazine (3-6 mg/Day) Cariprazine 3 milligrams (mg) - 6 mg capsules oral administration, once per day for 3 weeks. None None 9 167 89 167 View
Cariprazine (6-12 mg/Day) Cariprazine 6 mg - 12 mg capsules oral administration, once per day for 3 weeks. None None 5 169 90 169 View
Placebo Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks. None None 5 161 63 161 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.1 View
Endometrial cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 14.1 View
Mania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.1 View
Bipolar I disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Extrapyramidal disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 14.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View