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 @ 1:17 PM
Ignite Modification Date: 2025-12-25 @ 12:25 PM
NCT ID: NCT00266695
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00266695
Study Brief: Treatment for Completers of the Study B7A-MC-MBCM
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ruboxistaurin 32 mg given once daily as oral tablet for 2 years. None None 57 203 166 203 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Hypertensive heart disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Ischaemic cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.0 View
Acute abdomen SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Erosive oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Impaired gastric emptying SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Upper gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Generalised oedema SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.0 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Arthritis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gangrene SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Kidney infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Staphylococcal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Staphylococcal bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Wound infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Acetabulum fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Foot fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Pocket erosion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.0 View
Heart rate irregular SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.0 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.0 View
Fistula SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Thyroid cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.0 View
Brain stem infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Carotid artery occlusion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Cervicobrachial syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Diabetic nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.0 View
Toe amputation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Malignant hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Peripheral vascular disorder SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vitreous haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 11.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.0 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.0 View
Cataract operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View
Retinal laser coagulation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View
Vitrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 11.0 View