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 @ 3:37 AM
Ignite Modification Date: 2025-12-26 @ 2:21 AM
NCT ID: NCT03513302
Description: \*IN KEEPING WITH INSTITUTIONAL POLICIES, ALL INDIVIDUALS ENROLLED IN (CONSENTED FOR) THE STUDY WERE CONSIDERED "AT RISK", EVEN IF THEY DID NOT PASS SCREENING AND DID NOT RECEIVE THE INTERVENTION.\*
Frequency Threshold: 0
Time Frame: 14 days of first intervention + 14 days of washout + 14 days of second intervention
Study: NCT03513302
Study Brief: Dietary Nitrate and Muscle Power With Aging
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Screening Period Adverse events during screening, prior to arm/group assignment 0 None 0 47 27 47 View
Placebo Placebo (2 x 70 mL concentrated beet root juice depleted of nitrate per day) for 14 days 0 None 0 16 5 16 View
Nitrate Nitrate (2 x 70 mL concentrated beet root juice containing nitrate per day) for 14 days 0 None 0 16 4 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abnormal laboratory finding SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Abnormal laboratory finding SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Abnormal laboratory finding SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Abnormal laboratory finding SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Toothache SYSTEMATIC_ASSESSMENT General disorders None View
Muscle soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Syncope SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea/diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders None View
High blood pressure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abnormal laboratory finding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Epidermal cyst SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View