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: 2025-12-25 @ 2:41 AM
Ignite Modification Date: 2025-12-26 @ 1:19 AM
NCT ID: NCT00101933
Description: Adverse events collected during the blinded phase have been included, regardless of causality. Because the primary purpose of this adverse event summary is to compare the randomization groups, and because the additional non-randomized subject did not have a similar follow-up schedule, the subject has not been included in these analyses.
Frequency Threshold: 5
Time Frame: Adverse events were collected throughout the study. The summaries below include events that occurred during the blinded phase. A summary of device related events (operative phase through Year 2) is in the safety characterization objective.
Study: NCT00101933
Study Brief: SANTE - Stimulation of the Anterior Nucleus of the Thalamus for Epilepsy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
No Stimulation This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study. None None 6 55 41 55 View
Active Stimulation This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study. None None 2 54 42 54 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Implant site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (8.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (8.0) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (8.0) View
Complex partial seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Muscle contractions involuntary NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Partial seizures with secondary generalization NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Status epilepticus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (8.0) View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (8.0) View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (8.0) View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (8.0) View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (8.0) View
Confusional state NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (8.0) View
Complex partial seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Memory impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Paresthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Partial seizures with secondary generalization NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Simple partial seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (8.0) View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (8.0) View
Anticonvulsant toxicity NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (8.0) View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (8.0) View
Excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (8.0) View