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 @ 10:51 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
NCT ID: NCT00544869
Description: None
Frequency Threshold: 3
Time Frame: 7 Days for stopped at end of treated period 1 group 14 Days for continued at 15 or 30 mg/day group
Study: NCT00544869
Study Brief: A Study of OPC-41061 in Subjects With Cardiac-induced Edema (Congestive 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
Stopped at End of Treatment Period 1 Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days None None 3 36 30 36 View
Dose Escalated to 30 mg/Day Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2) None None 0 2 2 2 View
Continued at 15 mg/Day Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2) None None 1 13 12 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0)J View
Intracardiac Thrombus NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0)J View
Cerebral Artery Embolism NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0)J View
Renal Failure Chronic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0)J View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA (11.0)J View
Cardiac Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0)J View
Ventricular Extrasystoles NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0)J View
Ventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (11.0)J View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0)J View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0)J View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.0)J View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0)J View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Thirst NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0)J View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0)J View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (11.0)J View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Blood Alkaline Phosphatase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Blood Creatinine Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Blood Glucose Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Blood Lactate Dehydrogenase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Blood Potassium Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Blood Urea Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Blood Uric Acid Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Blood Urine Present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Glucose Urine Present NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
White Blood Cell Count Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0)J View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (11.0)J View
Hyperlipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (11.0)J View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (11.0)J View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (11.0)J View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (11.0)J View
Pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0)J View
Renal Impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (11.0)J View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.0)J View
Decubitus Ulcer NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (11.0)J View
Haemorrhage Subcutaneous NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (11.0)J View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (11.0)J View
Purpura NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (11.0)J View