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 @ 1:24 AM
Ignite Modification Date: 2025-12-25 @ 11:34 PM
NCT ID: NCT03133793
Description: SAEs defined per protocol and all remaining AEs categorized as Other AE without regard to treatment attribution.
Frequency Threshold: 1
Time Frame: Adverse events (AEs) were assessed every 4 weeks throughout treatment from time of first dose and up to the last day at 12 weeks. AEs were evaluated over treatment which was a maximum duration of 3 cycles (approximately 3 months).
Study: NCT03133793
Study Brief: CoQ10 and D-ribose in Patients With Diastolic Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
D-ribose Only Participants in this group will receive placebo pills and D-ribose oral powder. D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks. Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks. 0 None 5 33 1 33 View
Placebo Only Participants in this group will receive placebo pills and placebo powder. Placebo pills: Participants will take matched placebo pills that are 300 mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks. Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks. 0 None 8 38 2 38 View
CoQ10 + D-ribose Participants in this group will receive CoQ10 pills and D-ribose oral powder. CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks. D-Ribose Oral Powder: Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks. 1 None 7 33 2 33 View
CoQ10 Only Participants in this group will receive CoQ10 pills and placebo powder CoQ10: Participants will take 300 mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks. Placebo powder: Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks. 0 None 10 35 1 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View
Chest pain SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE View
Lung Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View
Hypokalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Gastric hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Fall SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCAE View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View
Pericardial Effusion SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View
Renal Colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCAE View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Soft tissue infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Bullous Dermatitis SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCAE View