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 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
NCT ID:
NCT01436305
Description:
None
Frequency Threshold:
5
Time Frame:
Enrollment through study completion, up to 3 years
Study:
NCT01436305
Study Brief:
Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Induction: Alemtuzumab, Maintenance: MMF + Tacrolimus | Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, which was adjusted to target trough levels of 8-12 ng/ml during the first 24 weeks post-transplant, then adjusted to target trough levels of 5-8 ng/ml thereafter. | 1 | None | 3 | 6 | 6 | 6 | View |
| Induction: Alemtuzumab, Maintenance: MMF + Belatacept | Induction: Alemtuzumab was administered in a single intravenous dose of 30 mg intra-operatively over a period of 2 hours. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was administered at a dose of 500 mg on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. | 0 | None | 5 | 6 | 4 | 6 | View |
| Induction: Basiliximab, Maintenance: MMF + Belatacept + Tac | Induction: Basiliximab was administered in 2 doses of 20 mg each, 2 hours prior to surgery and 4 days post-transplantation. Maintenance: Starting on the day of surgery or post-operative day one, participants underwent maintenance therapy. Mycophenolate mofetil (MMF) was given at a dose of 1000 mg by mouth twice a day of which was adjusted as clinically warranted. Mycophenolate sodium could be used to replace MMF at a dose 720 mg by mouth twice a day. Methylprednisone was given at a dose of 500 mg on Day 0, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant. Belatacept was given at a dose of 10 mg/kg on Day 0, then at days 4, 14, 28, 56 and 84. After Day 84, participants received 5 mg/kg every 4 weeks. Tacrolimus was given at a dose of 0.1 mg/kg twice a day by mouth, then adjusted to target trough levels: 8-12 ng/ml by Day 29, 5-8 ng/ml by Day 57, 3-5 ng/ml by Day 85 then stopped. | 0 | None | 5 | 7 | 7 | 7 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Suprapubic pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 14.1 | View |
| Arteriovenous graft site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Cytomegalovirus infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Infected skin ulcer | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Renal vein thrombosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Arterial thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Peripheral artery dissection | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Venous thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 14.1 | View |
| Transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 14.1 | View |
| Endocarditis staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 14.1 | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 14.1 | View |
| Asthenopia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 14.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 14.1 | View |
| Transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 14.1 | View |
| Type IV hypersensitivity reaction | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 14.1 | View |
| Acarodermatitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Urinary tract infection bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 14.1 | View |
| Complications of transplanted kidney | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Perirenal haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 14.1 | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Haematocrit increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Haemoglobin increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Liver function test abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Polyomavirus test positive | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| White blood cell count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 14.1 | View |
| Hypercalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 14.1 | View |
| Lipoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Tremor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.1 | View |
| Proteinuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Renal artery thrombosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 14.1 | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Night sweats | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 14.1 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 14.1 | View |