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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 11:44 PM
NCT ID:
NCT00965094
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00965094
Study Brief:
Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in 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 |
|---|---|---|---|---|---|---|---|---|
| Everolimus | At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 \[Month 3 (+1 week) after transplantation\], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively. | None | None | 7 | 19 | 19 | 19 | View |
| Reference Therapy | At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 \[Month 3 (+1 week) after transplantation\], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids. | None | None | 7 | 17 | 15 | 17 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | 17.0 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 17.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Brain neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 17.0 | View |
| Lung squamous cell carcinoma stage unspecified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 17.0 | View |
| Craniotomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 17.0 | View |
| Lymphocele | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Monocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | 17.0 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 17.0 | View |
| Sinus tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 17.0 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | 17.0 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 17.0 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Endocrine disorders | 17.0 | View |
| Orbital oedema | SYSTEMATIC_ASSESSMENT | Eye disorders | 17.0 | View |
| Abdominal distension | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Aphthous stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Oral discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Reflux oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 17.0 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 17.0 | View |
| Transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | 17.0 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Human polyomavirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 17.0 | View |
| Abdominal wound dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 17.0 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Blood lactate dehydrogenase | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Blood lactate dehydrogenase increased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Epstein-Barr virus test positive | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Hepatic enzyme increased | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | 17.0 | View |
| Hypercholesterolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Hyperuricaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Hypophosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | 17.0 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | 17.0 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 17.0 | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 17.0 | View |
| Bladder pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| Glycosuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| Ureteric stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| Vesicoureteric reflux | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 17.0 | View |
| Amenorrhoea | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | 17.0 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 17.0 | View |
| Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Blister | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 17.0 | View |
| Bladder anastomosis | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 17.0 | View |
| Urethral repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | 17.0 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 17.0 | View |