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:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
NCT ID:
NCT00658320
Description:
Combined data of adverse events that occurred in the Core and Extension studies.
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00658320
Study Brief:
Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Everolimus + Reduced Dose of Cyclosporine | An initial everolimus dose of 0.75 mg orally twice daily (1.5 mg/day) was administered 24-36 hours from reperfusion after transplantation and dose adjustments based on everolimus trough level (target trough level 3-8 ng/mL). Reduced dose of cyclosporine was initiated either pre-transplantation or within 24 hours after transplantation following the local regimen. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. Everolimus was available after 24 months for compassionate use. | None | None | 37 | 61 | 61 | 61 | View |
| Mycophenolate Mofetil (MMF) + Standard Dose of Cyclosporine | Patients were treated with 1 gram twice a day (2 grams/day) of Mycophenolate mofetil (MMF) and standard dose of cyclosporine for 12 months post renal transplant. Patients were treated with antibody induction therapy using 20 mg basiliximab two hours prior to transplant and 20 mg basiliximab 4 days post transplant or according to local practice. Corticosteroids were administered according to local practice. Patients were treated for 12 months in the core study and 12 months in the extension study. | None | None | 37 | 61 | 61 | 61 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Impaired healing | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Bile duct stenosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.0 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.0 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.0 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.0 | View |
| Hepatobiliary disease | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.0 | View |
| Adenoviral haemorrhagic cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Adenovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Cystitis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Cytomegalovirus viraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Mycobacterium avium complex infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Pertussis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Pneumocystis jiroveci pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Pneumonia bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Pneumonia cytomegaloviral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Renal cyst infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Lower limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Ureteric anastomosis complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Bacterial test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Blood beta-D-glucan increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Cytomegalovirus test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| HLA marker study positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Electrolyte imbalance | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Benign ovarian tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Diffuse large B-cell lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Thyroid cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | View |
| Calculus urinary | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Focal segmental glomerulosclerosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Glomerulonephritis membranous | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| IgA nephropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Nephropathy toxic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Nephrotic syndrome | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Renal tubular necrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Azoospermia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.0 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pneumomediastinum | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Upper respiratory tract inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Subcutaneous emphysema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Angiopathy | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Cataract nuclear | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Enteritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastric ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Rhinitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Incisional hernia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Kidney rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nephrogenic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Cushingoid | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 15.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Cytomegalovirus test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Low density lipoprotein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.0 | View |
| Bladder irritation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Nephropathy toxic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Tubulointerstitial nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Upper respiratory tract inflammation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Hirsutism | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
| Lymphocele | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.0 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hypoalbuminaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.0 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Osteoporosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Dizziness postural | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.0 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Dental caries | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.0 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Impaired healing | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.0 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.0 | View |
| Cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Cytomegalovirus viraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Oral herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.0 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Wound complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.0 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Blood creatine phosphokinase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Blood follicle stimulating hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Blood luteinising hormone increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.0 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.0 | View |
| Conjunctivitis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.0 | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.0 | View |