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 @ 11:21 PM
Ignite Modification Date: 2025-12-25 @ 9:04 PM
NCT ID: NCT01281956
Description: None
Frequency Threshold: 0
Time Frame: Adverse Events were collected following baseline history and physical examination and continued until study completion. Study duration was 42-46 weeks (+/- 4 weeks).
Study: NCT01281956
Study Brief: PRX-00023 Therapy in Localization-Related 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
Placebo Participants with epilepsy receiving placebo 0 None 0 10 7 10 View
PRX-0023 Participants with epilepsy receiving PRX-0023 0 None 0 9 4 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Itching NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small bumps on back NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bumps at IV site NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
GI Upset NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gait Imbalance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Elevated liver function test >2x normal NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Change in nails and hair NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Stomach flu NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Injury following seizure NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bug bites NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Weight gain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Increased appetite NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Achy and sweaty NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Chest pressure during sleep NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eye pain NON_SYSTEMATIC_ASSESSMENT Eye disorders None View