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 @ 3:37 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT01982292
Description: Safety set (SAF) - All patients who received at least one dose of study drug and had at least one post-Baseline safety assessment.
Frequency Threshold: 2
Time Frame: None
Study: NCT01982292
Study Brief: Safety of Repeat Doses of IV Serelaxin in Subjects With Chronic Heart Failure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RLX030 (Serelaxin) Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8 None None 30 212 65 212 View
Placebo Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8 None None 15 108 39 108 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
MULTI-ORGAN FAILURE SYSTEMATIC_ASSESSMENT General disorders 18.1 View
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME SYSTEMATIC_ASSESSMENT General disorders 18.1 View
APPENDICITIS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
DIARRHOEA INFECTIOUS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
EPIDIDYMITIS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
GANGRENE SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
GASTROENTERITIS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
OSTEOMYELITIS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
PERITONSILLAR ABSCESS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
PNEUMONIA STREPTOCOCCAL SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
STREPTOCOCCAL SEPSIS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
ALCOHOL POISONING SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 18.1 View
POST PROCEDURAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications 18.1 View
CAROTID ARTERY STENOSIS SYSTEMATIC_ASSESSMENT Nervous system disorders 18.1 View
SYNCOPE SYSTEMATIC_ASSESSMENT Nervous system disorders 18.1 View
VOCAL CORD PARALYSIS SYSTEMATIC_ASSESSMENT Nervous system disorders 18.1 View
ACUTE PSYCHOSIS SYSTEMATIC_ASSESSMENT Psychiatric disorders 18.1 View
SUICIDAL IDEATION SYSTEMATIC_ASSESSMENT Psychiatric disorders 18.1 View
ACUTE KIDNEY INJURY SYSTEMATIC_ASSESSMENT Renal and urinary disorders 18.1 View
HYDRONEPHROSIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders 18.1 View
ACUTE RESPIRATORY DISTRESS SYNDROME SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
CHRONIC OBSTRUCTIVE PULMONARY DISEASE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
RESPIRATORY FAILURE SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
HYPERTENSIVE EMERGENCY SYSTEMATIC_ASSESSMENT Vascular disorders 18.1 View
HYPOTENSION SYSTEMATIC_ASSESSMENT Vascular disorders 18.1 View
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE SYSTEMATIC_ASSESSMENT Vascular disorders 18.1 View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
ATRIAL FLUTTER SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
ATRIOVENTRICULAR BLOCK SECOND DEGREE SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
CARDIAC FAILURE ACUTE SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
CARDIAC FAILURE CHRONIC SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
CARDIOGENIC SHOCK SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
VENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
DIARRHOEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.1 View
HAEMORRHOIDAL HAEMORRHAGE SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 18.1 View
MEDICAL DEVICE SITE PAIN SYSTEMATIC_ASSESSMENT General disorders 18.1 View
OSTEOARTHRITIS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 18.1 View
BASAL CELL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 18.1 View
SQUAMOUS CELL CARCINOMA OF SKIN SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) 18.1 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 18.1 View
ACUTE MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
ANGINA UNSTABLE SYSTEMATIC_ASSESSMENT Cardiac disorders 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
OEDEMA PERIPHERAL SYSTEMATIC_ASSESSMENT General disorders 18.1 View
BRONCHITIS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
NASOPHARYNGITIS SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
PNEUMONIA SYSTEMATIC_ASSESSMENT Infections and infestations 18.1 View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders 18.1 View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 18.1 View
MUSCLE SPASMS SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders 18.1 View
DIZZINESS SYSTEMATIC_ASSESSMENT Nervous system disorders 18.1 View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders 18.1 View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders 18.1 View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders 18.1 View
HYPERTENSION SYSTEMATIC_ASSESSMENT Vascular disorders 18.1 View
INFUSION SITE EXTRAVASATION SYSTEMATIC_ASSESSMENT General disorders 18.1 View
NON-CARDIAC CHEST PAIN SYSTEMATIC_ASSESSMENT General disorders 18.1 View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders 18.1 View