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 @ 5:33 PM
Ignite Modification Date:
2025-12-25 @ 3:06 PM
NCT ID:
NCT00282568
Description:
Adverse events are reported for the modified safety analysis set defined as all patients who took at least 1 dose of tacrolimus MR during the pharmacokinetic period of the study.
Frequency Threshold:
5
Time Frame:
From the first dose of tacrolimus MR formulation through the day of last dose plus 10 days (approximately 60 months).
Study:
NCT00282568
Study Brief:
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant 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 |
|---|---|---|---|---|---|---|---|---|
| Tacrolimus Modified Release | Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons. | None | None | 39 | 67 | 48 | 67 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Cellulitis staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Clostridium colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Hepatitis c | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Human polyomavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Orchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Pneumonitis cryptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Sepsis syndrome | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Tracheobronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Abdominal pain lower | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Abdominal strangulated hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Anal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Coeliac disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Diarrhoea haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Palatal dysplasia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Squamous cell carcinoma of skin | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Bowen's disease | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Lung Nodule | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Lymphoproliferative disorder | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Papilloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Renal cell carcinoma stage unspecified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Tonsil cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Tumour lysis syndrome | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (6.1) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (6.1) | View |
| Renal insufficiency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (6.1) | View |
| Glomerulonephritis focal | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (6.1) | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (6.1) | View |
| Tubulointestitial nephritis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (6.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (6.1) | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (6.1) | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (6.1) | View |
| Gout | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (6.1) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (6.1) | View |
| Hypervolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (6.1) | View |
| Hypovolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (6.1) | View |
| Arteriovenous graft site complications | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Complications of transplant surgery | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Drug toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Incisional hernia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Intentional misuse | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Medication error | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Post procedural diarrhoea | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Renal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Upper limb fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (6.1) | View |
| Aseptic necrosis bone | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Myopathy | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |
| Pelvic mass | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | View |
| Bronchospasm | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | View |
| Dysphonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | View |
| Malignant hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (6.1) | View |
| Gangrene | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (6.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (6.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (6.1) | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (6.1) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (6.1) | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (6.1) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (6.1) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (6.1) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (6.1) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (6.1) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (6.1) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (6.1) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (6.1) | View |
| Amyloidosis | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (6.1) | View |
| Kidney transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (6.1) | View |
| Ectopic pregnancy | SYSTEMATIC_ASSESSMENT | Pregnancy, puerperium and perinatal conditions | MedDRA (6.1) | View |
| Vulvar Dysplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (6.1) | View |
| Pregnancy of partner | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (6.1) | View |
| Renal transplant | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (6.1) | View |
| Localised osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Urinary tract infection enterococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (6.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (6.1) | View |
| Pharyngolaryngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (6.1) | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (6.1) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (6.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (6.1) | View |