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 @ 11:46 AM
Ignite Modification Date: 2025-12-26 @ 10:19 AM
NCT ID: NCT00292461
Description: None
Frequency Threshold: 3
Time Frame: None
Study: NCT00292461
Study Brief: A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized 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
Lamotrigine once daily orally for 16 weeks None None 1 30 20 30 View
Zonegran once or twice daily orally for 16 weeks None None 0 34 20 34 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lumber contusion None Musculoskeletal and connective tissue disorders None View
nystagmus None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Disturbance in attention None Nervous system disorders None View
dizziness None Nervous system disorders None View
Gait disturbance None Nervous system disorders None View
insomnia None Nervous system disorders None View
nystagmus None Nervous system disorders None View
somnolence None Nervous system disorders None View
White blood cell urine positive None Investigations None View
Blood alkaline phosphatase increased None Investigations None View
Electrocardiogram abnormal None Investigations None View
Hepatic enzyme abnormal None Investigations None View
Red blood cell urine positive None Investigations None View
Weight decreased None Investigations None View
Mood altered None Psychiatric disorders None View
nausia None Gastrointestinal disorders None View
Abdominal distention None Gastrointestinal disorders None View
anorexia None Metabolism and nutrition disorders None View
malaise None General disorders None View
splenomegaly None Blood and lymphatic system disorders None View
Hepatic function disorders None Hepatobiliary disorders None View
diplopia None Eye disorders None View
Vision blurred None Eye disorders None View
contusion None Musculoskeletal and connective tissue disorders None View
pruritus None Skin and subcutaneous tissue disorders None View
rash None Skin and subcutaneous tissue disorders None View