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 @ 12:45 AM
Ignite Modification Date: 2025-12-25 @ 10:59 PM
NCT ID: NCT00412867
Description: None
Frequency Threshold: 2
Time Frame: 3 months
Study: NCT00412867
Study Brief: Post-marketing Clinical Study of Alteplase for Acute Ischemic Stroke （Japan Alteplase Clinical Trial Ⅱ：J-ACT Ⅱ）
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Alteplase (Non-Haemorrhage) 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour None None 12 58 51 58 View
Alteplase (Haemorrhage) 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour None None 1 58 25 58 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastric cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) 11.0 View
Uterine leiomyoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) 11.0 View
Cerebral infarction None Nervous system disorders 11.0 View
Cardiac failure None Cardiac disorders 11.0 View
Sick sinus syndrome None Cardiac disorders 11.0 View
Acute left ventricular failure None Cardiac disorders 11.0 View
Inguinal hernia None Gastrointestinal disorders 11.0 View
Melaena None Gastrointestinal disorders 11.0 View
Cholecystitis None Hepatobiliary disorders 11.0 View
Pneumonia None Infections and infestations 11.0 View
Septic shock None Infections and infestations 11.0 View
Pneumonia aspiration None Respiratory, thoracic and mediastinal disorders 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Atrial fibrillation None Cardiac disorders 11.0 View
Bradycardia None Cardiac disorders 11.0 View
Mitral valve incompetence None Cardiac disorders 11.0 View
Tachycardia None Cardiac disorders 11.0 View
Tricuspid valve incompetence None Cardiac disorders 11.0 View
Constipation None Gastrointestinal disorders 11.0 View
Diarrhoea None Gastrointestinal disorders 11.0 View
Mouth haemorrhage None Gastrointestinal disorders 11.0 View
Nausea None Gastrointestinal disorders 11.0 View
Vomiting None Gastrointestinal disorders 11.0 View
Pyrexia None General disorders 11.0 View
Urinary tract infections None Infections and infestations 11.0 View
Alanine aminotransferase increased None Investigations 11.0 View
Aspartate aminotransferase increased None Investigations 11.0 View
Blood bilirubin increased None Investigations 11.0 View
Blood creatine phosphokinase increased None Investigations 11.0 View
Blood fibrinogen increased None Investigations 11.0 View
Blood lactate dehydrogenase increased None Investigations 11.0 View
Blood pressure increased None Investigations 11.0 View
Blood urea increased None Investigations 11.0 View
Blood urine present None Investigations 11.0 View
Liver function test abnormal None Investigations 11.0 View
Protein urine present None Investigations 11.0 View
Diabetes mellitus None Metabolism and nutrition disorders 11.0 View
Hyponatraemia None Metabolism and nutrition disorders 11.0 View
Hyperlipidaemia None Metabolism and nutrition disorders 11.0 View
Arthralgia None Musculoskeletal and connective tissue disorders 11.0 View
Back pain None Musculoskeletal and connective tissue disorders 11.0 View
Pain in extremity None Musculoskeletal and connective tissue disorders 11.0 View
Periarthritis None Musculoskeletal and connective tissue disorders 11.0 View
Cervicobrachial syndrome None Nervous system disorders 11.0 View
Haemorrhagic cerebral infarction None Nervous system disorders 11.0 View
Headache None Nervous system disorders 11.0 View
Insomnia None Psychiatric disorders 11.0 View
Restlessness None Psychiatric disorders 11.0 View
Dysuria None Renal and urinary disorders 11.0 View
Haematuria None Renal and urinary disorders 11.0 View
Neurogenic bladder None Renal and urinary disorders 11.0 View
Benign prostatic hyperplasia None Reproductive system and breast disorders 11.0 View
Pharyngolaryngeal pain None Respiratory, thoracic and mediastinal disorders 11.0 View
Pneumonia aspiration None Respiratory, thoracic and mediastinal disorders 11.0 View
Dermatitis contact None Skin and subcutaneous tissue disorders 11.0 View
Erythema None Skin and subcutaneous tissue disorders 11.0 View
Haemorrhage subcutaneous None Skin and subcutaneous tissue disorders 11.0 View
Skin exfoliation None Skin and subcutaneous tissue disorders 11.0 View
Deep vein thrombosis None Vascular disorders 11.0 View
Hepatic function abnormal None Hepatobiliary disorders 11.0 View
Liver disorder None Hepatobiliary disorders 11.0 View
Nasopharyngitis None Infections and infestations 11.0 View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders 11.0 View
Osteoarthritis None Musculoskeletal and connective tissue disorders 11.0 View