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 @ 12:32 PM
Ignite Modification Date:
2025-12-25 @ 12:10 PM
NCT ID:
NCT00765661
Description:
None
Frequency Threshold:
5
Time Frame:
Adverse events were collected from Day 1 and up to end of study for a total of 12 months.
Study:
NCT00765661
Study Brief:
Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo 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 |
|---|---|---|---|---|---|---|---|---|
| Group A | LCP - Tacro™ tablets, once daily (LifeCycle Pharma A/S, Hørsholm DK) tacrolimus (Tacro™): LCP - Tacro™ tablets | None | None | 15 | 32 | 32 | 32 | View |
| Group B | Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL) Prograf®: Prograf® capsules, twice daily | None | None | 17 | 31 | 30 | 31 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| localized infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| ureteric stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| obstructive uropathy | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| vulval cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| vomitting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| acute renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| serum sickness | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (Unspecified) | View |
| haemturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| wound drainage | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (Unspecified) | View |
| bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (Unspecified) | View |
| pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| renal lymphocele | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| post procedural urine leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| complications of transplanted kidney | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| lymph node tuberculosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| oesphagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| lymphocele | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| musculoskeletal chest pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| incisional hernia | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| anemia macrocytic | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| coagulophathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| internal normalized ratio increase | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| renal tubular necrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| drug intolerance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Gait disturbance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Impaired healing | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Non-cardiac chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (Unspecified) | View |
| Kidney transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (Unspecified) | View |
| Seasonal allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (Unspecified) | View |
| Transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (Unspecified) | View |
| BK virus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Human papylomavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (Unspecified) | View |
| Complications of transplanted kidney | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Incision site complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Incision site pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Prost procedural discharge | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (Unspecified) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hyperlipidaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Vitamin D deficiency | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (Unspecified) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | View |
| Burning sensation | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (Unspecified) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (Unspecified) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Renal tubular necrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (Unspecified) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Nasal congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Rhinitis allergic | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | View |
| Wound drainage | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (Unspecified) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Lymphocele | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (Unspecified) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (Unspecified) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (Unspecified) | View |
| Ear discomfort | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (Unspecified) | View |
| Ear pain | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (Unspecified) | View |
| Hyperparathyroidism | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (Unspecified) | View |
| Abdominal Distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Abdominal lower pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Flatulence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Mouth Ulceration | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (Unspecified) | View |
| Drug toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (Unspecified) | View |