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 @ 4:37 PM
Ignite Modification Date: 2025-12-25 @ 2:28 PM
NCT ID: NCT01061866
Description: During the trial we observed two serious adverse events, one of them presented exacerbation of seizures, another patient showed sedation, at 3 and 7 months respectively to the beginning of treatment. Other adverse events consisted in sensory neuropathy in 2 out of 7 patients tested with nerve conduction studies.
Frequency Threshold: 4
Time Frame: 1 year
Study: NCT01061866
Study Brief: Thalidomide Low Threshold in 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
Thalidomide Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment. None None 2 7 1 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
sedation SYSTEMATIC_ASSESSMENT Nervous system disorders other View
seizures exacerbation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders other View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
sensorial neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders other View