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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT02245620
Description: None
Frequency Threshold: 2
Time Frame: 36 days
Study: NCT02245620
Study Brief: A Phase 2 Study to Evaluate the Impact of MTP-131 (Bendavia™) on Skeletal Muscle Function in Elderly
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Elamipretide Elamipretide given as an intravenous infusion of 0.25 mg/kg/hr at a rate of 60 mL/hr for 2 hours. Elamipretide: Elamipretide 0.25 mg/kg/hour administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours 0 None 0 19 3 19 View
Placebo Placebo (lyophilized excipients without elamipretide) given as an intravenous infusion at a rate of 60 mL/hr for 2 hours. Placebo: Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours 0 None 0 20 2 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (19.0) View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (19.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 19.0 View
Vessel puncture site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA (19.0) View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (19.0) View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (19.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.0 View