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 @ 5:24 PM
Ignite Modification Date: 2025-12-25 @ 2:59 PM
NCT ID: NCT03472950
Description: None
Frequency Threshold: 5
Time Frame: Adverse event data was collected for 12 weeks. This began at baseline visit through the week 12 visit.
Study: NCT03472950
Study Brief: Safety and Efficacy of Ranolazine for the Treatment of Amyotrophic Lateral Sclerosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ranolazine 500mg Participants will take Ranolazine 500mg twice daily for up to 4 weeks. Ranolazine 500 MG: Ranolazine is an FDA approved drug for angina (ongoing chest pain or pressure that is felt when the heart does not get enough oxygen). 0 None 0 6 4 6 View
Ranolazine 1000mg Participants will take Ranolazine 1000mg twice daily for up to 4 weeks. Ranolazine 1000 MG: Ranolazine is an FDA approved drug for angina (ongoing chest pain or pressure that is felt when the heart does not get enough oxygen). 0 None 0 8 7 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Indigestion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dental Abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Drowsiness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper extremity weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Decreased muscle tone NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Urine odor NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Worsening muscle cramps NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastroesophageal reflux NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View