Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:10 AM
Ignite Modification Date: 2025-12-26 @ 12:38 AM
NCT ID: NCT02457260
Description: None
Frequency Threshold: 5
Time Frame: patients were assessed over 4 weeks of the nitrite intervention
Study: NCT02457260
Study Brief: Oral Nitrite for Older Heart Failure Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Control 12 healthy adults, age 70 or older to receive 14 Nitrogen (14N) sodium nitrite, 40 mg tid 14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks 0 None 0 12 10 12 View
HFpEF 7 adults with heart failure and preserved ejection fraction age 70 or older to receive 14N sodium nitrite, 20 or 40 mg tid depending on dose stratification for safety 14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks 0 None 0 7 6 7 View
HFrEF 2 adults with heart failure and reduced ejection fraction aged 70 or older to receive 14N sodium nitrite, 20 or 40 mg tid depending on dose stratification for safety 14 N Sodium Nitrite: oral formulation of sodium nitrite 40 mg three times daily for 4 weeks 0 None 0 2 1 2 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
dizzy NON_SYSTEMATIC_ASSESSMENT General disorders None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blood Blister NON_SYSTEMATIC_ASSESSMENT General disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Belly Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Impaired Depth Perception NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Knee Strain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
leg cramps NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
leg twinge NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lightheadedness NON_SYSTEMATIC_ASSESSMENT General disorders None View
Lumbrosacral strain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Malaise With Flu NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscle tightness- upper leg NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
nausea NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Nocturia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Tension in Head NON_SYSTEMATIC_ASSESSMENT General disorders None View
URI NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT General disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Cramp NON_SYSTEMATIC_ASSESSMENT General disorders None View
Twinge NON_SYSTEMATIC_ASSESSMENT General disorders None View
Itchy Eyes NON_SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increase in poor coordination NON_SYSTEMATIC_ASSESSMENT General disorders None View
Scaly itchy patch on thigh NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
increased heart rate NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
syncopal episode NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest tightness NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Change in blood pressure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
back pain resolved NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
leg cramps resolved NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diastolic NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Shin spasm pain recurring NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View