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 @ 7:49 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT00772603
Description: Safety was assessed using adverse events (AEs), clinical laboratory results, vital signs, physical and neurological examinations, and electrocardiograms (ECGs).
Frequency Threshold: 5
Time Frame: All randomized subjects who took at least one dose of study drug.
Study: NCT00772603
Study Brief: Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial 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
2400mg/Day SPN-804 2400mg total daily dose of SPN-804O once a day (QD), given as four 600mg tablets None None 10 123 69 123 View
1200mg/Day SPN-804 1200mg total daily dose of SPN-804O QD, given as two 600mg tablets and two identical placebo tablets. None None 7 122 57 122 View
Placebo placebo QD, given as four placebo tablets None None 7 121 55 121 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Drug intolerance SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Skull fractured, base SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Lactate dehydrogenase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyponatreamia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Pituitary tumor, benign SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Ovarian cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Convulsions/complex partial seizures SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Post-ictal state SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nystagmus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pityriasis rosea SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Rash generalized SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Stevens-Johnson Syndrome SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Balance Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diplopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View