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 @ 5:34 PM
Ignite Modification Date: 2025-12-25 @ 3:06 PM
NCT ID: NCT01397968
Description: None
Frequency Threshold: 5
Time Frame: 12 week double-blind treatment period plus taper period (2-3 weeks)
Study: NCT01397968
Study Brief: Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo: capsule, dose to be titrated to a target dose of 200mg/day 0 None 4 109 69 109 View
YKP3089 YKP3089: Capsule, dose to be titrated to a target dose of 200mg/day 0 None 3 113 86 113 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Drug hypersensitivity reaction NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (16.0) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Status epilepticus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Arteriogram coronary normal NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (16.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (16.0) View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (16.0) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Nystagmus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Balance disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (16.0) View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View