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 @ 10:17 PM
Ignite Modification Date:
2025-12-25 @ 7:50 PM
NCT ID:
NCT00666835
Description:
None
Frequency Threshold:
5
Time Frame:
Recording of AEs included periods before first application and until the end of application of study medication. Occurrence of AEs was recorded from time when patient had given his/her informed consent until the final visit of the main study period (visit 28). By definition, AEs starting in the period after first application until the end of the main period were considered to be 'treatment-emergent' AEs. Analysis based on safety population: patients received at least 1 dose of treatment.
Study:
NCT00666835
Study Brief:
Study to Evaluate the Efficacy and Safety of HX575 Hexal AG vs ERYPO® for the Treatment of Anemia in Hemodialysis 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 |
|---|---|---|---|---|---|---|---|---|
| HX575 Epoetin Alfa Hexal AG | Eligible patients were switched from the comparator to HX575 epoetin alfa Hexal AG in ratio 2:1 to be intravenously (solution for injection i.v.) treated with HX575 in pre-filled syringes for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28. | 19 | None | 112 | 314 | 283 | 314 | View |
| ERYPO®, Janssen-Cilag | Eligible patients were randomized and continued to be treated with ERYPO®, Janssen-Cilag in pre-filled syringes intravenously (solution for injection i.v.) for 24 weeks. The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels between 10-13 g/dL. Baseline HB value after 24 weeks was required for efficacy analysis at week 28. | 5 | None | 57 | 164 | 154 | 164 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Influenza viral infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Pseudomonal infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Skin structures and soft tissue infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Staphylococcal infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Upper respiratory tract infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Vascular infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Viral infections NEC | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Cardiac and vascular procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Lower limb fractures and dislocations | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Non-site specific procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Cerebral injuries NEC | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Fractures and dislocations NEC | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Limb injuries NEC (incl traumatic amputation) | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Device failure and malfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Device related complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Non-site specific injuries NEC | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Site specific injuries NEC | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Thoracic cage fractures and dislocations | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Upper limb fractures and dislocations | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Urinary tract procedural complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Ischaemic coronary artery disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Rate and rhythm disorders NEC | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Heart failures NEC | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Supraventricular arrhythmias | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Ventricular arrhythmias and cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Coronary artery disorders NEC | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Aortic valvular disorders | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Cardiac disorders NEC | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Cardiomyopathies | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Peripheral vasoconstriction, necrosis and vascular insufficiency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Accelerated and malignant hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Aneurysms and dissections non-site specific | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Non-site specific necrosis and vascular insufficiency NEC | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Vascular hypertensive disorders NEC | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Vascular hypotensive disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Peripheral embolism and thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Haemorrhages NEC | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Site specific necrosis and vascular insufficiency NEC | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Vena caval embolism and thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Acute and chronic pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastric ulcers and perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastritis (excl infective) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Non-site specific gastrointestinal haemorrhages | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Diverticula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastrointestinal inflammatory disorders NEC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Benign neoplasms gastrointestinal (excl oral cavity) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Duodenal ulcers and perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Dyspeptic signs and symptoms | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastrointestinal and abdominal pains (excl oral and throat) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastrointestinal signs and symptoms NEC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastrointestinal spastic and hypermotility disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastrointestinal vascular occlusion and infarction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Haemorrhoids and gastrointestinal varices (excl oesophageal) | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Inguinal hernias | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Intestinal ulcers and perforation NEC | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Nausea and vomiting symptoms | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Peritoneal and retroperitoneal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Peritoneal and retroperitoneal haemorrhages | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Bronchospasm and obstruction | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Pneumothorax and pleural effusions NEC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Pulmonary oedemas | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Breathing abnormalities | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Lower respiratory tract inflammatory and immunologic conditions | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Respiratory failures (excl neonatal) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Nasal disorders NEC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Parenchymal lung disorders NEC | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Pulmonary thrombotic and embolic conditions | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Central nervous system haemorrhages and cerebrovascular accidents | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Central nervous system vascular disorders NEC | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Seizures and seizure disorders NEC | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Coma states | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Disturbances in consciousness NEC | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Mononeuropathies | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Paralysis and paresis (excl congenital and cranial nerve) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Febrile disorders | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Implant and catheter site reactions | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Body temperature perception | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Death and sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| General signs and symptoms NEC | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Healing abnormal NEC | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Trophic disorders | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Colonic neoplasms malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Laryngeal neoplasms malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Metastases to specified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Rectal neoplasms malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Renal cell carcinomas | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Respiratory tract small cell carcinomas | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Skin neoplasms malignant and unspecified (excl melanoma) | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Soft tissue neoplasms benign NEC | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Cholecystitis and cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.0) | View |
| Cholestasis and jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.0) | View |
| Osteoarthropathies | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Arthropathies NEC | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Musculoskeletal and connective tissue signs and symptoms NEC | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Myopathies | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Skin and subcutaneous tissue ulcerations | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Dermal and epidermal conditions NEC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Rashes, eruptions and exanthems NEC | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Renal disorders NEC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Bladder infections and inflammations | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Renal obstructive disorders | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Renal vascular and ischaemic conditions | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Arterial therapeutic procedures (excl aortic) | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (8.0) | View |
| Vascular therapeutic procedures NEC | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (8.0) | View |
| Joint therapeutic procedures | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (8.0) | View |
| Hypoglycaemic conditions NEC | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Calcium metabolism disorders NEC | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Diabetes mellitus (incl subtypes) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Total fluid volume increased | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Carbohydrate tolerance analyses (incl diabetes) | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.0) | View |
| ECG investigations | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.0) | View |
| Gastrointestinal histopathology procedures | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (8.0) | View |
| Hyperparathyroid disorders | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (8.0) | View |
| Confusion and disorientation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Depressive disorders | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Anaemias NEC | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.0) | View |
| Inner ear signs and symptoms | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (8.0) | View |
| Cataracts (excl congenital) | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (8.0) | View |
| Transplant rejections | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (8.0) | View |
| Lower respiratory tract and lung infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Bacterial infections NEC | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Sepsis, bacteraemia and viraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Infections NEC | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Abdominal and gastrointestinal infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Bone and joint infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Streptococcal infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Urinary tract infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Cardiac infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Haemodialysis-induced symptom | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Procedural hypotension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Procedural hypertension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Arteriovenous fistula site complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Shoulder pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |