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 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:44 PM
NCT ID: NCT02670551
Description: Safety Population included all participants in the randomized population who took at least 1 dose of double-blind investigational product.
Frequency Threshold: 5
Time Frame: First dose to 30 days past last dose (Up to 80 Days)
Study: NCT02670551
Study Brief: Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
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 1.5 mg Following a 7 to 14 days screening/washout period, cariprazine 1.5 milligram (mg) capsule, one per day, orally for 6 weeks. 0 None 2 157 48 157 View
Placebo Following a 7 to 14 days screening/washout period, placebo-matching cariprazine capsule, one per day, orally for 6 weeks. 0 None 2 158 43 158 View
Cariprazine 3.0 mg Following a 7 to 14 days screening/washout period, cariprazine 1.5 mg capsule, one per day for 2 weeks followed by cariprazine 3.0 mg capsule, one per day, orally beginning on Day 15 for 4 weeks. 0 None 2 165 62 165 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 20.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 20.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 20.0 View
Iron deficiency anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA version 20.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 20.0 View
Chronic tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA version 20.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 20.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 20.0 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 20.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 20.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 20.0 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 20.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 20.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 20.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA version 20.0 View