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 @ 6:55 PM
Ignite Modification Date: 2025-12-25 @ 4:28 PM
NCT ID: NCT01276457
Description: Population includes all the enrolled patients in the overall core and extension study.
Frequency Threshold: 5
Time Frame: 24 months
Study: NCT01276457
Study Brief: Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Upper Everolimus Blood Target + Very Low Dose Cyclosporine Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study. None None 85 142 142 142 View
Standard Everolimus Blood Target + Low Dose Cyclosporine Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study. None None 90 143 142 143 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Bone marrow toxicity SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Haemolytic uraemic syndrome SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiomyopathy SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiovascular disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Coronary artery stenosis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Hydrocele SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Pulmonary arteriovenous fistula SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Orbital oedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA View
Abdominal compartment syndrome SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Aphthous stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Ascites SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Enterovesical fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Intestinal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Malabsorption SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Subileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Implant site effusion SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Mucosal inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Portal hypertension SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA View
Kidney transplant rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Transplant rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Abdominal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchitis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Bronchopulmonary aspergillosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Ear infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Infected lymphocele SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Omphalitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumocystis jiroveci pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pulmonary tuberculosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Relapsing fever SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Subcutaneous abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Arterial injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Chronic allograft nephropathy SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Complications of transplanted kidney SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Drug toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Graft dysfunction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Kidney rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Perinephric collection SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Perirenal haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Therapeutic agent toxicity SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Arterial bruit SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Biopsy endometrium SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood culture positive SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood pressure decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Blood urea increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Creatine urine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Cytomegalovirus test SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Legionella serology SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Epithelioma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Liposarcoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Anuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Calculus bladder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Diffuse mesangial sclerosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Focal glomerulosclerosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephritis interstitial SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephropathy SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Nephropathy toxic SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal artery stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Ureteral disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Ureteric stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urinary tract disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Urogenital fistula SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Vesicoureteric reflux SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Metrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Ovarian cyst torsion SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Interstitial lung disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pneumonitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Cholecystectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Inguinal hernia repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Lymphocele marsupialisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Nephrectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Nephrostomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Parathyroidectomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Removal of ambulatory peritoneal catheter SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Stent removal SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Ureteric repair SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Arteriovenous fistula SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Haemorrhage SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Lymphocele SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Lymphorrhoea SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Venous thrombosis limb SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Kidney transplant rejection SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Cytomegalovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Complications of transplanted kidney SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Transaminases increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA View
Acidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Dyslipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Fluid retention SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypercholesterolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperlipidaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypertriglyceridaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hyperuricaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Iron deficiency SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Proteinuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Ovarian cyst SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Lymphocele SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View