Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 5:08 PM
Ignite Modification Date: 2025-12-25 @ 2:46 PM
NCT ID: NCT00642850
Description: Only adverse events with an onset date after the start of medication included.
Frequency Threshold: 5
Time Frame: Up to 28 weeks
Study: NCT00642850
Study Brief: STABIL Study: National Study With Mircera for Maintenance of Hemoglobin Level in Dialysis 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
C.E.R.A. Adult participants with chronic renal disease and who had received intravenous epoetin maintenance treatment, received intravenous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 24 weeks. None None 41 188 38 188 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coeliac artery stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Dyspepsia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastric ulcer haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastric ulcer perforation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Haemorrhoidal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Intestinal angina NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Intestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Sudden death NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Arteriovenous fistula site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Catheter sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Chlamydial infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Haematoma infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Herpes zoster NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Sepsis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Wound infection staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Arteriovenous fistula site complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Complications of transplanted kidney NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Graft complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Humerus fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Post procedural haemorrhage NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Arteriogram NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Arteriogram coronary NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
Fluid retention NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
Polymyalgia rheumatica NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Spondylolisthesis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Benign pancreatic neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Lung carcinoma cell type unspecified stage III NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cerebral haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Subarachnoid haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Breast dysplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Hydrothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Dry gangrene NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
Arteriovenous fistula operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Coronary artery bypass NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Aneurysm ruptured NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Shock NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Atrioventricular block NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Myocardial ischaemia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Ventricular fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View