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 @ 3:39 AM
Ignite Modification Date: 2025-12-26 @ 2:23 AM
NCT ID: NCT02002702
Description: None
Frequency Threshold: 5
Time Frame: Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
Study: NCT02002702
Study Brief: Study of Safety, Tolerability and Pharmacokinetics of Serelaxin in Japanese Acute Heart Failure (AHF) Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Serelaxin 10 mcg/kg/Day Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours. None None 1 16 10 16 View
Serelaxin 30 mcg/kg/Day Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours. None None 3 15 9 15 View
Placebo Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours. None None 0 15 9 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
GASTRIC CANCER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
METASTASES TO LIVER SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
METASTASES TO PERITONEUM SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
OESOPHAGEAL CARCINOMA SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CORONARY ARTERY STENOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
VENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
INTESTINAL ISCHAEMIA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
MULTI-ORGAN FAILURE SYSTEMATIC_ASSESSMENT General disorders MedDRA View
METASTASES TO LYMPH NODES SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
IRON DEFICIENCY ANAEMIA SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CARDIAC FAILURE CONGESTIVE SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
VENTRICULAR EXTRASYSTOLES SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
VENTRICULAR TACHYCARDIA SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
CONSTIPATION SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
INFUSION SITE PAIN SYSTEMATIC_ASSESSMENT General disorders MedDRA View
HYPERBILIRUBINAEMIA SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
BACTERIAL INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
INFLUENZA SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
URINARY TRACT INFECTION SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
BLOOD PRESSURE DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
BLOOD PRESSURE SYSTOLIC DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
PLATELET COUNT DECREASED SYSTEMATIC_ASSESSMENT Investigations MedDRA View
DEHYDRATION SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOGLYCAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPOKALAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HYPONATRAEMIA SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
HEADACHE SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
DELIRIUM SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
INSOMNIA SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
RESTLESSNESS SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
HAEMATURIA SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
RENAL IMPAIRMENT SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
GENITAL PAIN SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
EPISTAXIS SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
DERMATITIS CONTACT SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
ERYTHEMA SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
PSORIASIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA View
VASCULITIS SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View