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: 2025-12-24 @ 11:44 PM
Ignite Modification Date: 2025-12-25 @ 9:36 PM
NCT ID: NCT03043651
Description: None
Frequency Threshold: 5
Time Frame: The study duration was 25 months overall. The study was discontinued by the Sponsor on 14 October 2019 due to slow enrollment in the parent study, TDE-HF-301.
Study: NCT03043651
Study Brief: Open-label Extension of Oral Treprostinil in Subjects With PH Associated With HFpEF
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oral Treprostinil Sustained-release tablets for TID administration Oral Treprostinil: Sustained-release oral tablets for TID administration 1 None 19 48 47 48 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Azotaemia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Death SYSTEMATIC_ASSESSMENT General disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations None View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gastrointestinal angiectasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypervolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypochloraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Normochromic normocytic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Pneumonia mycoplasmal SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pulmonary hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus node dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders None View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders None View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Oedema SYSTEMATIC_ASSESSMENT General disorders None View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations None View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
N-terminal prohormone brain natriuretic peptide increased SYSTEMATIC_ASSESSMENT Investigations None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pain in jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
Chest pain SYSTEMATIC_ASSESSMENT General disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View