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 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT00440466
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00440466
Study Brief: PROCRIT Extended Dosing For Maintenance of Hemoglobin in Pre-Dialysis CKD 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
Epoetin Alfa QW Continue pre-study once weekly dose of epoetin alfa for 36 weeks None None 24 108 59 108 View
Epoetin Alfa Q2W Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks None None 28 107 59 107 View
Epoetin Alfa Q4W Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk None None 56 215 116 215 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Cardio-respiratory arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Cardiomyopathy NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Coronary artery occlusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Sick sinus syndrome NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 11.1 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Alcoholic pancreatitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Diverticulum NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Diverticulum intestinal haemorrhagic NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Duodenal ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Gastric antral vascular ectasia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Gastric mucosal lesion NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Gastric ulcer NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Large intestine perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Lower gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Oesophageal ulcer haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Small intestinal obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Upper gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Sudden cardiac death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Chest discomfort NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Cholelithiasis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
Gallbladder disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
Liver disorder NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 11.1 View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Intervertebral discitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Lobar pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Paronychia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Pharyngeal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Sepsis syndrome NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Urosepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Foot fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Hip fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
Post procedural myocardial infarction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 11.1 View
International normalised ratio increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 11.1 View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Fluid overload NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Osteoporosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Spinal column stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Breast cancer in situ NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Metastatic carcinoid tumour NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Pancreatic carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Uterine cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 11.1 View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Cervical cord compression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Hepatic encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Vascular dementia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.1 View
Renal failure acute NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Renal failure chronic NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Renal impairment NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Azotaemia NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Haematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Urinary retention NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 11.1 View
Pulmonary oedema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Lung infiltration NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Increased tendency to bruise NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 11.1 View
Deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Aortic aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Hypertensive crisis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Peripheral vascular disorder NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Arteriosclerosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Haemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Thrombophlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Hypercoagulation NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Splenic cyst NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Cardiac failure congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 11.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 11.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Oedema NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Hyperkalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 11.1 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.1 View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 11.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 11.1 View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 11.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.1 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 11.1 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 11.1 View