Trial Outcomes & Findings for Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients (NCT NCT00240994)
NCT ID: NCT00240994
Last Updated: 2017-01-02
Results Overview
Graft loss is defined as the need for dialysis for more than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Up to one year post kidney transplantation procedure
Results posted on
2017-01-02
Participant Flow
Four centers in the United States recruited 35 subjects between January 2005 and October 2007 who were less than 21 years of age and first time living-donor kidney allograft recipients.
At a screening visit, participants underwent procedures to establish inclusion/exclusion criteria and then sign the informed consent form.
Participant milestones
| Measure |
Alemtuzumab (Campath)
In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Alemtuzumab (Campath)
In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Graft failure
|
1
|
Baseline Characteristics
Safety in Immunomodulatory Functions of Alemtuzumab (Campath) in Pediatric Kidney Transplantation Recipients
Baseline characteristics by cohort
| Measure |
Alemtuzumab (Campath)
n=35 Participants
In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
|
|---|---|
|
Age, Continuous
Final status: Completed (N=22)
|
13.1 years
STANDARD_DEVIATION 5.0 • n=99 Participants
|
|
Age, Continuous
Final status: Discontinued Therapy (N=10)
|
9.8 years
STANDARD_DEVIATION 6.2 • n=99 Participants
|
|
Age, Continuous
Final status: Discontinued Study (N=3)
|
17.7 years
STANDARD_DEVIATION 2.4 • n=99 Participants
|
|
Age, Continuous
All Participants (N=35)
|
12.6 years
STANDARD_DEVIATION 5.5 • n=99 Participants
|
|
Gender
Female
|
20 Participants
n=99 Participants
|
|
Gender
Male
|
15 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to one year post kidney transplantation procedurePopulation: Intent-to-treat
Graft loss is defined as the need for dialysis for more than 30 days duration, allograft nephrectomy, or the decision to withdraw immunosuppression due to graft failure.
Outcome measures
| Measure |
Alemtuzumab (Campath)
n=35 Participants
In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
|
|---|---|
|
The Proportion of Participants With Graft Loss or Death Within 12 Months Post Kidney Transplantation
|
0.057 Proportion of participants
|
Adverse Events
Alemtuzumab (Campath)
Serious events: 25 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Alemtuzumab (Campath)
n=35 participants at risk
In this open-label, single-arm trial , participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.4%
4/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Abdominal compartment syndrome
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Ascites
|
2.9%
1/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
4/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Adverse drug reaction
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Oedema
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Pyrexia
|
14.3%
5/35 • Number of events 5 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Immune system disorders
Graft loss
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Immune system disorders
Hypersensitivity
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Immune system disorders
Kidney transplant rejection
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Immune system disorders
Transplant rejection
|
8.6%
3/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Adenovirus infection
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Arthritis bacterial
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Bacterial pyelonephritis
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Catheter site cellulitis
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Cellulitis
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Central line infection
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Gastroenteritis
|
8.6%
3/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Herpes simplex
|
2.9%
1/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Influenza
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Klebsiella infection
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Lobar pneumonia
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Pneumonia
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Pyelonephritis
|
5.7%
2/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Rhinovirus infection
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Blood creatinine increased
|
11.4%
4/35 • Number of events 6 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Blood culture positive
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Dehydration
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Musculoskeletal and connective tissue disorders
Epiphyseal disorder
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Nervous system disorders
Grand mal convulsion
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Psychiatric disorders
Depressed mood
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Renal and urinary disorders
Anuria
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Renal and urinary disorders
Glomerulonephritis focal
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Renal and urinary disorders
Proteinuria
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Renal and urinary disorders
Renal failure
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Renal and urinary disorders
Urinoma
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Reproductive system and breast disorders
Epididymitis
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.9%
1/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
2.9%
1/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Surgical and medical procedures
Gastrostomy closure
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Surgical and medical procedures
Suture removal
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Vascular disorders
Hypotension
|
2.9%
1/35 • Number of events 1 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
Other adverse events
| Measure |
Alemtuzumab (Campath)
n=35 participants at risk
In this open-label, single-arm trial , participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
57.1%
20/35 • Number of events 35 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Blood and lymphatic system disorders
Leukopenia
|
65.7%
23/35 • Number of events 70 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Blood and lymphatic system disorders
Lymphopenia
|
11.4%
4/35 • Number of events 6 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Blood and lymphatic system disorders
Neutropenia
|
40.0%
14/35 • Number of events 26 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
4/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Anal ulcer
|
5.7%
2/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Diarrhoea
|
34.3%
12/35 • Number of events 15 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Mouth ulceration
|
14.3%
5/35 • Number of events 11 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Nausea
|
8.6%
3/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Stomatitis
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Gastrointestinal disorders
Vomiting
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Fatigue
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Infusion related reaction
|
11.4%
4/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Oedema peripheral
|
8.6%
3/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Pain
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
General disorders
Pyrexia
|
20.0%
7/35 • Number of events 9 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Immune system disorders
Cytokine release syndrome
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Immune system disorders
Transplant rejection
|
5.7%
2/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Bronchitis
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Bronchitis acute
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Cellulitis
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Chronic sinusitis
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Cystitis klebsiella
|
11.4%
4/35 • Number of events 8 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Ear infection
|
5.7%
2/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Gastroenteritis
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Impetigo
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Nasopharyngitis
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Otitis media
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Sinusitis
|
20.0%
7/35 • Number of events 10 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Upper respiratory tract infection
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Urinary tract infection
|
14.3%
5/35 • Number of events 8 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Urinary tract infection enterococcal
|
8.6%
3/35 • Number of events 6 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Infections and infestations
Viraemia
|
8.6%
3/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Injury, poisoning and procedural complications
Post procedural pain
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Blood cholesterol increased
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Blood creatine phosphokinase increased
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Blood creatinine increased
|
14.3%
5/35 • Number of events 7 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Blood parathyroid hormone increased
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Blood pressure increased
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Epstein-Barr virus antibody positive
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Haematocrit decreased
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Haemoglobin decreased
|
14.3%
5/35 • Number of events 9 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Neutrophil count decreased
|
5.7%
2/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Transferrin saturation decreased
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Investigations
Weight increased
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Dehydration
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Food intolerance
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.4%
4/35 • Number of events 5 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
17.1%
6/35 • Number of events 7 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
22.9%
8/35 • Number of events 8 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
17.1%
6/35 • Number of events 7 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
5/35 • Number of events 8 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
25.7%
9/35 • Number of events 11 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.6%
3/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Nervous system disorders
Headache
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Nervous system disorders
Migraine
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Psychiatric disorders
Anxiety
|
8.6%
3/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Psychiatric disorders
Depression
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Psychiatric disorders
Insomnia
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Psychiatric disorders
Panic attack
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Renal and urinary disorders
Haematuria
|
11.4%
4/35 • Number of events 4 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Renal and urinary disorders
Hydronephrosis
|
8.6%
3/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Renal and urinary disorders
Hypercalciuria
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Renal and urinary disorders
Proteinuria
|
14.3%
5/35 • Number of events 7 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
11.4%
4/35 • Number of events 5 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
2/35 • Number of events 2 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.7%
2/35 • Number of events 3 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
|
Vascular disorders
Hypertension
|
45.7%
16/35 • Number of events 18 • From beginning of study to end of study
This study graded the severity of adverse events experienced by the study participants according to criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 3.0 (June 10, 2003)
|
Additional Information
Associate Director, Clinical Research Program
DAIT/NIAID
Phone: 301-594-7669
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place