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 @ 7:19 PM
Ignite Modification Date: 2025-12-25 @ 4:58 PM
NCT ID: NCT00576303
Description: Serious adverse events and non-serious adverse events are reported in the safety population.
Frequency Threshold: 0
Time Frame: Up to 3 years
Study: NCT00576303
Study Brief: A Study of Intravenous Mircera in Dialysis Patients With Chronic Renal Disease and Anemia.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
RO0503821 (1x/4 Weeks) Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of \<8000, 8000-16000, or \>16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks None None 45 200 78 200 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cardiac failure acute SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pancreatitis chronic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Peritonitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Device dislocation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Ill-defined disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Cholestasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Orchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pyelonephritis chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pyonephrosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Renal cyst infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Arteriovenous fistula aneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Arteriovenous fistula thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Peritoneal dialysis complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Traumatic haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Glucose tolerance impaired SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Osteonecrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Colon neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Pancreatic carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Diabetic coma SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Bronchitis chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Haemorrhagic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Bundle branch block left SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Conduction disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Extrasystoles SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Conjunctival haemorrhage SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Myopia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Retinopathy hypertensive SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Duodenal ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Erosive oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastric ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastritis atrophic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastritis erosive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastroduodenitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrooesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastrooesophageal sphincter insufficiency SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haemorrhagic erosive gastritis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haemorrhoidal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Hiatus hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Melaena SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Periodontitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Reflux oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Hyperthermia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Cholecystitis chronic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Acute sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Hepatitis C SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Postoperative wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pulpitis dental SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pyelonephritis chronic SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pyonephrosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Respiratory tract infection viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Viral hepatitis carrier SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Anaemia postoperative SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Arteriovenous fistula site haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Arteriovenous fistula thrombosis SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Scapula fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Vascular access complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Metabolic acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Polydipsia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Osteochondrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Periostitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Synovitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Lipoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Carpal tunnel syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Diabetic neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hypotonia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Intercostal neuralgia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Intracranial aneurysm SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Radiculitis cervical SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Radiculitis lumbosacral SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Calculus urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Cystitis noninfective SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal colic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal cyst SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Bronchitis chronic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pleurisy SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Dermatitis allergic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Purpura SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Aortic arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Post thrombotic syndrome SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Tracheitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Post procedural fistula SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Procedural hypertension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Procedural hypotension SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Benign breast neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Ill-defined disorder SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View