Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:38 PM
Ignite Modification Date: 2025-12-25 @ 9:28 PM
NCT ID: NCT01127256
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT01127256
Study Brief: Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zonisamide Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day. None None 5 96 74 96 View
Carbamazepine Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day. None None 9 104 70 104 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Worsening Insomnia None Psychiatric disorders None View
Depressive Mood None Psychiatric disorders None View
Right Shoulder Injury None General disorders None View
Visual Hallucination None Psychiatric disorders None View
Cervical Sprain None General disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Uterine Fibroid None Reproductive system and breast disorders None View
Sgot Increased None Investigations None View
Diabetic Ketoacidosis None Metabolism and nutrition disorders None View
Memory And Judgement Disturbance None Psychiatric disorders None View
Urticaria None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Dysuria None Renal and urinary disorders None View
Constipation None Gastrointestinal disorders None View
Sgpt Increased None Investigations None View
Mental Torpor None Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mental Torpor None Psychiatric disorders None View
Gastrointestinal Pain None Gastrointestinal disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Sleep Disorder None Psychiatric disorders None View
Fatigue None General disorders None View
Depression None Psychiatric disorders None View
Constipation None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Dizziness None Nervous system disorders None View
Anorexia None Gastrointestinal disorders None View
Weight Decrease None Investigations None View
Drowsiness None Psychiatric disorders None View
Headache None Nervous system disorders None View
Nausea None Gastrointestinal disorders None View
Memory Impairment None Psychiatric disorders None View
Pyrexia None General disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Diarrhoea None Gastrointestinal disorders None View
Urticaria None Skin and subcutaneous tissue disorders None View