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 @ 3:54 AM
Ignite Modification Date: 2025-12-26 @ 2:43 AM
NCT ID: NCT03015402
Description: None
Frequency Threshold: 0
Time Frame: From Baseline through study completion, up to 26 weeks
Study: NCT03015402
Study Brief: Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants who received placebo in the first or last 10 weeks of the study. 0 None 0 24 23 24 View
Oral Nitrite Participants who received Oral Nitrite in the first or last 10 weeks of the study. 0 None 0 24 22 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hand,Food, and mouth SYSTEMATIC_ASSESSMENT Infections and infestations None View
Dizziness/Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Inflammation of Ear SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Vision Disturbance SYSTEMATIC_ASSESSMENT Eye disorders None View
Conjuctivitis SYSTEMATIC_ASSESSMENT Eye disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Joint Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chest Cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Stent Procedure (leg) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Inflammation Right Ear SYSTEMATIC_ASSESSMENT Infections and infestations None View
Volume Overload SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Tightness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Systolic Murmur SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Earache SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Influenza SYSTEMATIC_ASSESSMENT General disorders None View
Swelling of Extremity SYSTEMATIC_ASSESSMENT General disorders None View
SARS-CoV-2 Virus SYSTEMATIC_ASSESSMENT General disorders None View
Abscess of tooth SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Chills SYSTEMATIC_ASSESSMENT General disorders None View
Cramps SYSTEMATIC_ASSESSMENT General disorders None View
Increased Potassium SYSTEMATIC_ASSESSMENT General disorders None View
Cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Gout Flare SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Muscle Strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Increased Respiratory Rate SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Bibasilar Crackles SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View