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 @ 10:55 PM
Ignite Modification Date: 2025-12-25 @ 8:23 PM
NCT ID: NCT04712669
Description: An adverse event (AE) is any untoward medical occurrence in a patient, temporally associated with the use of investigational product (IP), whether or not considered related to the IP.
Frequency Threshold: 0.05
Time Frame: Up to 48 weeks
Study: NCT04712669
Study Brief: A Study of Rodatristat Ethyl in Patients With Pulmonary Arterial Hypertension (Core OLE)
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-Rodatristat Ethyl 300 mg Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase 2 None 2 15 12 15 View
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 600 mg Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase 0 None 0 2 2 2 View
Rodatristat Ethyl 600 Mg-Rodatristat Ethyl 600 mg Subjects whose actual treatment group is Rodatristat ethyl two 600 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase 0 None 3 21 17 21 View
Rodatristat Ethyl 300 mg BID MAIN study: Rodatristat ethyl 300 mg and placebo tablet BID + standard of care medication(s) taken for 24 weeks 1 None 9 36 32 36 View
Rodatristat Ethyl 600 mg BID MAIN study:Rodatristat ethyl two 300 mg tablets BID + standard of care medication(s) taken for 24 weeks 0 None 6 36 34 36 View
Placebo MAIN study: Matching two placebo tablets BID+ standard of care medication(s) taken for 24 weeks 0 None 1 36 27 36 View
Placebo-Rodatristat Ethyl 600 mg Subjects whose actual treatment group is Placebo in the double-blind phase (Main Study) and received Rodatristat ethyl two 600 mg tablets BID in the open-label phase 0 None 4 16 15 16 View
Rodatristat Ethyl 300 Mg-Rodatristat Ethyl 300 mg Subjects whose actual treatment group is Rodatristat ethyl two 300 mg in the double-blind phase (Main Study) and received Rodatristat ethyl two 300 mg tablets BID in the open-label phase 0 None 6 22 12 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory syncytial virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Device related thrombosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Electrocardiogram QT prolonged SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Anticoagulation drug level below therapeutic SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Transplant evaluation SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Device extrusion SYSTEMATIC_ASSESSMENT Product Issues MedDRA 24.0 View
Device breakage SYSTEMATIC_ASSESSMENT Product Issues MedDRA 24.0 View
Device malfunction SYSTEMATIC_ASSESSMENT Product Issues MedDRA 24.0 View
Pulmonary arterial hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Lung infiltration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia influenzal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Helicobacter infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Infusion site infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Vaginal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24.0 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24.0 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Ageusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Anosmia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Hypotonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Sinus tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Pericardial effusion SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Ventricular extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Productive cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Pulmonary arterial hypertension SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Dysphonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Upper-airway cough syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Eructation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Gastrointestinal sounds abnormal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Chest discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Peripheral swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Device related thrombosis SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Lithiasis SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Anticoagulation drug level below therapeutic SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood alkaline phosphatase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Platelet count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
White blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood pH increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood potassium decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Pancreatic enzymes increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
SARS-CoV-2 test positive SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 24.0 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Essential hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24.0 View
Congestive hepatopathy SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Nocturia SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Ureterolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24.0 View
Prostatomegaly SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 24.0 View