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 @ 12:13 AM
Ignite Modification Date: 2025-12-25 @ 10:14 PM
NCT ID: NCT02481258
Description: Our definitions of AE and SAE do not differ from those provided on clinicaltrials.gov. For this study, adverse events were identified through regularly scheduled follow-up phone calls by study staff.
Frequency Threshold: 0
Time Frame: Adverse event data were acquired during the periods of patient enrollment (from 6 months to a maximum of 12 months of treatment duration). The total study duration was 3 years.
Study: NCT02481258
Study Brief: A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ataciguat (HMR1766) 200mg taken daily for 6 months Ataciguat (HMR1766) 0 None 1 12 9 12 View
Matching Placebo Taken Daily for 6 months Placebo Comparator: Matching Placebo 0 None 1 12 10 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Elevated Liver Enzymes SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hospitalization due progression of disease SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dizziness/Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nosebleed SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rash/Dry Skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tired/Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Odor in urine SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Chest Pain/Tightness SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lower back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Mood Changes SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ankle Edema SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall (study unrelated) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Runny Nose (Common Cold) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hot Flashes SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nausea SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Prostate Cancer (study unrelated) SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cholesterol lab values out of range SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Muscle Cramps/Aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fever SYSTEMATIC_ASSESSMENT Infections and infestations None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Indigestion SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Cough (related to cold/flu) SYSTEMATIC_ASSESSMENT Infections and infestations None View
Low Hemoglobin SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arm Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View