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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT00852202
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00852202
Study Brief: Safety and Efficacy of RGH-188 (Cariprazine) in Bipolar 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
1.5 to 3.0 mg Cariprazine 1.5 to 3.0 mg Cariprazine capsules, orally administrated once daily for 8 weeks None None 2 75 52 75 View
Placebo Matching placebo capsules, orally administered for 8 weeks None None 2 77 51 77 View
0.25 to 0.75 mg Cariprazine Cariprazine capsules 0.25 to 0.75 mg was orally administrated once daily for 8 weeks None None 2 75 48 75 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA version 13.0 View
Abortion spontaneous SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MeDRA version 13.0 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA version 13.0 View
Bipolar I disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA version 13.0 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA version 13.0 View
Suicidal attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA version 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA version 13.0 View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA version 13.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA version 13.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA version 13.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA version 13.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MeDRA version 13.0 View
Weight Increase SYSTEMATIC_ASSESSMENT Investigations MeDRA version 13.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA version 13.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA version 13.0 View
Restlessness SYSTEMATIC_ASSESSMENT Psychiatric disorders MeDRA version 13.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA version 13.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MeDRA version 13.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA version 13.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA version 13.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MeDRA version 13.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA version 13.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA version 13.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA version 13.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA version 13.0 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MeDRA version 13.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MeDRA version 13.0 View