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: 2025-12-26 @ 11:11 PM
Ignite Modification Date: 2025-12-26 @ 11:11 PM
NCT ID: NCT02362412
Description: None
Frequency Threshold: 0
Time Frame: From first dose of study drug up to 7 days after last dose of study drug (22 weeks)
Study: NCT02362412
Study Brief: Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Period II FK949E 50 mg Participants who received FK949E 50 mg tablets once daily during Treatment Period II (8 weeks). None None 0 9 1 9 View
Treatment Period II FK949E 150 mg Participants who received FK949E 150 mg tablets once daily duringr Treatment Period II (8 weeks). None None 0 11 2 11 View
Treatment Period III FK949E 150 mg Participants who received FK949E 150 mg tablets once daily during Treatment Period III (8 weeks). None None 0 9 5 9 View
Treatment Period III FK949E 50 mg Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks). None None 0 11 2 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation None Gastrointestinal disorders MedDRA/J v18.0 View
Stomatitis None Gastrointestinal disorders MedDRA/J v18.0 View
Abdominal pain upper None Gastrointestinal disorders MedDRA/J v18.0 View
Nausea None Gastrointestinal disorders MedDRA/J v18.0 View
Nasopharyngitis None Infections and infestations MedDRA/J v18.0 View
Upper respiratory tract infection None Infections and infestations MedDRA/J v18.0 View
Vulvovaginal candidiasis None Infections and infestations MedDRA/J v18.0 View
Muscle strain None Injury, poisoning and procedural complications MedDRA/J v18.0 View
Blood creatine phosphokinase increased None Investigations MedDRA/J v18.0 View
Hyperaesthesia None Nervous system disorders MedDRA/J v18.0 View
Hypertonic bladder None Renal and urinary disorders MedDRA/J v18.0 View
Yawning None Respiratory, thoracic and mediastinal disorders MedDRA/J v18.0 View
Eczema None Skin and subcutaneous tissue disorders MedDRA/J v18.0 View
Urticaria None Skin and subcutaneous tissue disorders MedDRA/J v18.0 View