Trial Outcomes & Findings for Islet Transplantation for Type 1 Diabetes (NCT NCT00014911)

Last Updated: 2017-03-15

Results Overview

Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1.) a blood glycosylated hemoglobin (HbA1c) level \< 6.5% (Normal:\<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal: \<140mg/dL if \<=50 years of age, \<150 mg/dL for ages 50-60 years and \<160 mg/dL for ages 60+)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

36 participants

Primary outcome timeframe

One year status post participant receipt of final islet transplantation

Results posted on

2017-03-15

Participant Flow

Nine centers recruited participants 18 to 65 years of age who had Type 1 diabetes mellitus for more than five years, recurrent neuroglycopenia that included reduced awareness of their hypoglycemic episodes or severe glycemic lability, and fulfilled all eligibility criteria. Refer to the Eligibility section for more details.

Participant milestones

Participant milestones
Measure	Islet Transplantation Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Overall Study STARTED	36
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Islet Transplantation Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Overall Study Adverse Event	1
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	6
Overall Study Unknown Reasons	2
Overall Study Immunosuppression-related Side Effects	1

Baseline Characteristics

Islet Transplantation for Type 1 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Islet Transplantation n=36 Participants Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Age, Continuous	40.9 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Race/Ethnicity, Customized Race: White	35 Participants n=5 Participants
Race/Ethnicity, Customized Race: Unspecified	1 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity: Non-Hispanic	36 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Region of Enrollment Canada	4 participants n=5 Participants
Region of Enrollment Germany	4 participants n=5 Participants
Region of Enrollment Italy	4 participants n=5 Participants
Region of Enrollment Switzerland	5 participants n=5 Participants
Number of Years with Diabetes	27 Years STANDARD_DEVIATION 10.4 • n=5 Participants
Daily Insulin Usage	0.5 Units of Insulin/kilogram/day (U/kg/day) STANDARD_DEVIATION 0.1 • n=5 Participants

PRIMARY outcome

Timeframe: One year status post participant receipt of final islet transplantation

Population: Intent-to-treat

Outcome measures

Outcome measures
Measure	Islet Transplantation n=36 Participants Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation. Insulin Independence at One Year	44 Percent of Participants
Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation. Insulin Independence with One Transplant	14 Percent of Participants
Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation. Insulin Independence with Two Transplants	17 Percent of Participants
Percent of Participants That Achieved Insulin Independence With Adequate Control of Blood Glucose Levels at One Year Post Final Islet Transplantation. Insulin Independence with Three Transplants	14 Percent of Participants

SECONDARY outcome

Timeframe: One year post receipt of final islet transplantation

Population: Intent-to-treat

Partial islet function definition: a fasting basal C-peptide level \>= 0.3 ng/mL and a continuing need for insulin or suboptimal glycemic control (Note: C-peptide is a substance that the pancreas releases into the bloodstream in equal amounts to insulin, thereby showing how much insulin the body is making). Adequate glycemic control is defined by: 1) a blood HbA1c level \<6.5%, 2) a blood glucose level after an overnight fast not exceeding 140 mg/dL more than three times in any week and, 3) a 2-hour postprandial blood glucose level not exceeding 180 mg/dL more than four times per week

Outcome measures

Outcome measures
Measure	Islet Transplantation n=36 Participants Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Percent of Participants With Partial Islet Function One Year Post Final Islet Transplantation.	28 Percent of Participants

SECONDARY outcome

Timeframe: First transplantation until end of study (up to six years post final transplantation)

Population: Intent-to-Treat

Insulin independence: exogenous insulin not required and glycemic control is achieved as defined by maintaining 1) a blood glycosylated hemoglobin (HbA1c) level \< 6.5% (Normal:\<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher),2) a blood glucose level after an overnight fast not exceeding 140 mg per deciliter (dL) more than three times in any week (Normal: 70 to 120 mg/dL), and 3)not exceeding a 2-hour postprandial blood glucose level of 180 mg/dL more than four times per week (Normal: \<140mg/dL if \<=50 years of age, \<150 mg/dL for ages 50-60 years and \<160 mg/dL for ages 60+)

Outcome measures

Outcome measures
Measure	Islet Transplantation n=36 Participants Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Percent of Participants That Achieved Insulin Independence From First Transplant	58 Percent of Participants

SECONDARY outcome

Timeframe: Two years post first transplantation

Population: Intent-to-Treat

C-peptide is a substance that the pancreas releases into the bloodstream in equal amounts to insulin, thereby showing how much insulin the body is making. C-peptide secretion is used to measure the function of transplanted islets. Higher levels indicate better islet function. Detectable fasting basal levels of C-peptide secretion are \>=0.3 ng/ml.

Outcome measures

Outcome measures
Measure	Islet Transplantation n=36 Participants Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Percent of Participants With Detectable Fasting Basal C-Peptide Levels	70 Percent of Participants

POST_HOC outcome

Timeframe: First transplantation through August 30, 2010 (up to 9 years)

Population: Intent-to-Treat

Seven participants from US sites were included in the extended follow-up. These participants were monitored yearly from year three post last transplantation (the original end of study follow-up) through August 30, 2010 (up to 9 years post first transplantation), at which point they were transferred to a new protocol (ITN040CT \[NCT01309022\]). Glycosylated hemoglobin (HbA1c) is a measure of the average plasma glucose concentration over prolonged periods of time. (Normal:\<5.7%; pre-diabetes: 5.7% -6.4%; diabetes: 6.5% or higher)

Outcome measures

Outcome measures
Measure	Islet Transplantation n=7 Participants Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
HbA1c Plasma Laboratory Values for Participants in the Extended Follow-up Study Phase	6.2 HbA1c Percentage Interval 6.0 to 6.5

POST_HOC outcome

Timeframe: First transplantation through August 30, 2010 (up to 9 years)

Population: Intent-to-Treat

Seven participants from US sites were included in the extended follow-up. These participants were monitored yearly from year three post last transplantation (the original end of study follow-up) through August 30, 2010 (up to 9 years post first transplantation), at which point they were transferred to a new protocol (ITN040CT \[NCT01309022\]). Serum creatinine is a measure of renal function. Normal ranges are from 0.5 to 1.0 mg/dL for females and 0.7 to 1.2 mg/dL for males.

Outcome measures

Outcome measures
Measure	Islet Transplantation n=7 Participants Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Serum Creatinine Levels for Participants in the Extended Follow-up Study Phase	0.9 mg/dL Interval 0.7 to 1.6

Adverse Events

Islet Transplantation

Serious events: 17 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Islet Transplantation n=36 participants at risk Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Blood and lymphatic system disorders Anaemia	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Blood and lymphatic system disorders Neutropenia	11.1% 4/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Cardiac disorders Myocardial infarction	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Ear and labyrinth disorders Vertigo	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Ascites	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Diarrhoea	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Gastritis	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Gastrointestinal haemorrhage	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Mouth ulceration	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Peritoneal haemorrhage	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Peritonitis	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Vomiting	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Chest pain	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Fatigue	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Pyrexia	5.6% 2/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Appendiceal abscess	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Cystitis	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Herpes virus infection	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Pyelonephritis	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Injury, poisoning and procedural complications Hepatic haematoma	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Dehydration	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Musculoskeletal and connective tissue disorders Myalgia	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic haemangioma rupture	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Psychiatric disorders Conversion disorder	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Psychiatric disorders Depression	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Psychiatric disorders Suicidal ideation	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Renal and urinary disorders Renal failure acute	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Diarrhoea hemorrhage	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Gastroenteritis	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Injury, poisoning and procedural complications Hip fracture	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hyperglycaemia	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hypoglycaemia	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Upper respiratory tract infection	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Cardiac disorders Pericardial effusion	2.8% 1/36 • Number of events 1 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)

Other adverse events

Other adverse events
Measure	Islet Transplantation n=36 participants at risk Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications: 1. Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation. 2. Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study. 3. Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression.
Blood and lymphatic system disorders Anaemia	80.6% 29/36 • Number of events 133 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Blood and lymphatic system disorders Iron deficiency anaemia	11.1% 4/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Blood and lymphatic system disorders Leukopenia	75.0% 27/36 • Number of events 119 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Blood and lymphatic system disorders Lymphopenia	25.0% 9/36 • Number of events 30 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Blood and lymphatic system disorders Neutropenia	52.8% 19/36 • Number of events 114 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Blood and lymphatic system disorders Thrombocytopenia	22.2% 8/36 • Number of events 43 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Cardiac disorders Bradycardia	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Cardiac disorders Palpitations	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Cardiac disorders Pericardial effusion	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Ear and labyrinth disorders Ear pain	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Ear and labyrinth disorders Vertigo	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Eye disorders Vision blurred	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Eye disorders Vitreous floaters	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Eye disorders Vitreous haemorrhage	5.6% 2/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Abdominal distension	5.6% 2/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Abdominal pain	33.3% 12/36 • Number of events 20 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Abdominal pain lower	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Abdominal pain upper	27.8% 10/36 • Number of events 13 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Aphthous stomatitis	11.1% 4/36 • Number of events 6 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Constipation	11.1% 4/36 • Number of events 6 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Diarrhoea	63.9% 23/36 • Number of events 52 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Dyspepsia	11.1% 4/36 • Number of events 8 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Flatulence	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Haemorrhoids	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Lip ulceration	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Loose stools	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Mouth ulceration	91.7% 33/36 • Number of events 138 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Nausea	52.8% 19/36 • Number of events 28 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Tongue ulceration	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Gastrointestinal disorders Vomiting	41.7% 15/36 • Number of events 31 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Asthenia	13.9% 5/36 • Number of events 8 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Chest discomfort	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Chest pain	5.6% 2/36 • Number of events 5 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Fatigue	38.9% 14/36 • Number of events 24 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Influenza like illness	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Malaise	5.6% 2/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Mucosal ulceration	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Oedema	16.7% 6/36 • Number of events 6 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Oedema peripheral	25.0% 9/36 • Number of events 13 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Pain	16.7% 6/36 • Number of events 8 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Pyrexia	30.6% 11/36 • Number of events 15 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
General disorders Rigors	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Hepatobiliary disorders Portal hypertension	11.1% 4/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Immune system disorders Hypersensitivity	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Bronchitis	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Cellulitis	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Clostridium colitis	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Folliculitis	11.1% 4/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Fungal infection	8.3% 3/36 • Number of events 7 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Herpes simplex	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Herpes zoster	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Hordeolum	5.6% 2/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Influenza	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Nasopharyngitis	30.6% 11/36 • Number of events 12 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Onychomycosis	11.1% 4/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Rhinitis	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Sinusitis	11.1% 4/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Tonsillitis	5.6% 2/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Tooth abscess	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Upper respiratory tract infection	22.2% 8/36 • Number of events 10 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Urinary tract infection	25.0% 9/36 • Number of events 13 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Vaginal candidiasis	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Vaginal mycosis	11.1% 4/36 • Number of events 6 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Infections and infestations Viral infection	5.6% 2/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Injury, poisoning and procedural complications Contusion	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Injury, poisoning and procedural complications Excoriation	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Injury, poisoning and procedural complications Incision site complication	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Alanine aminotransferase increased	25.0% 9/36 • Number of events 14 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Aspartate aminotransferase increased	27.8% 10/36 • Number of events 17 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Band neutrophil percentage increased	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Blood albumin decreased	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Blood alkaline phosphatase increased	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Blood bicarbonate decreased	13.9% 5/36 • Number of events 18 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Blood chloride increased	5.6% 2/36 • Number of events 9 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Blood cholesterol increased	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Blood lactate dehydrogenase increased	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Blood urea increased	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Hepatic enzyme increased	33.3% 12/36 • Number of events 20 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Liver function test abnormal	38.9% 14/36 • Number of events 20 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Mean cell volume decreased	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Red blood cell count decreased	13.9% 5/36 • Number of events 14 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations Weight decreased	25.0% 9/36 • Number of events 11 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Investigations White blood cell count decreased	8.3% 3/36 • Number of events 7 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Anorexia	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Decreased appetite	11.1% 4/36 • Number of events 5 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hyperchloraemia	8.3% 3/36 • Number of events 6 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hypercholesterolaemia	33.3% 12/36 • Number of events 18 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hyperglycaemia	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hyperlipidaemia	19.4% 7/36 • Number of events 9 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hypernatraemia	5.6% 2/36 • Number of events 8 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hypertriglyceridaemia	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hypocalcaemia	13.9% 5/36 • Number of events 9 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hypoglycaemia	30.6% 11/36 • Number of events 24 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hypoglycaemia unawareness	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hypokalaemia	8.3% 3/36 • Number of events 7 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hypomagnesaemia	13.9% 5/36 • Number of events 25 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hyponatraemia	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Metabolism and nutrition disorders Hypophosphataemia	11.1% 4/36 • Number of events 10 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Musculoskeletal and connective tissue disorders Arthralgia	22.2% 8/36 • Number of events 17 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Musculoskeletal and connective tissue disorders Back pain	11.1% 4/36 • Number of events 6 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Musculoskeletal and connective tissue disorders Chest wall pain	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Musculoskeletal and connective tissue disorders Joint swelling	5.6% 2/36 • Number of events 6 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Musculoskeletal and connective tissue disorders Muscle cramp	16.7% 6/36 • Number of events 9 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	5.6% 2/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Musculoskeletal and connective tissue disorders Myalgia	11.1% 4/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 3/36 • Number of events 5 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Nervous system disorders Amnesia	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Nervous system disorders Burning sensation	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Nervous system disorders Dizziness	11.1% 4/36 • Number of events 5 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Nervous system disorders Headache	55.6% 20/36 • Number of events 53 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Nervous system disorders Hypoaesthesia	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Nervous system disorders Memory impairment	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Nervous system disorders Migraine	11.1% 4/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Nervous system disorders Paraesthesia	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Nervous system disorders Tremor	25.0% 9/36 • Number of events 13 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Psychiatric disorders Anxiety	5.6% 2/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Psychiatric disorders Depression	11.1% 4/36 • Number of events 5 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Psychiatric disorders Insomnia	16.7% 6/36 • Number of events 8 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Renal and urinary disorders Nocturia	5.6% 2/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Renal and urinary disorders Proteinuria	8.3% 3/36 • Number of events 6 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Renal and urinary disorders Renal cyst	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Reproductive system and breast disorders Menstrual disorder	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Reproductive system and breast disorders Menstruation irregular	13.9% 5/36 • Number of events 7 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Reproductive system and breast disorders Ovarian cyst	8.3% 3/36 • Number of events 7 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Reproductive system and breast disorders Vaginal discharge	5.6% 2/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Respiratory, thoracic and mediastinal disorders Cough	30.6% 11/36 • Number of events 16 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.6% 2/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Respiratory, thoracic and mediastinal disorders Epistaxis	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 3/36 • Number of events 5 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	36.1% 13/36 • Number of events 19 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	11.1% 4/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Respiratory, thoracic and mediastinal disorders Sinus congestion	11.1% 4/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Acne	41.7% 15/36 • Number of events 25 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Dermatitis acneiform	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Dermatitis contact	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Eczema	5.6% 2/36 • Number of events 7 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Erythema	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Ingrowing nail	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Nail disorder	8.3% 3/36 • Number of events 3 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Pruritus	19.4% 7/36 • Number of events 10 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Purpura	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Rash	36.1% 13/36 • Number of events 18 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Rash papular	8.3% 3/36 • Number of events 6 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Rash pruritic	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Skin and subcutaneous tissue disorders Skin lesion	8.3% 3/36 • Number of events 4 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Vascular disorders Haematoma	11.1% 4/36 • Number of events 5 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Vascular disorders Hot flush	5.6% 2/36 • Number of events 2 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Vascular disorders Hypertension	19.4% 7/36 • Number of events 11 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)
Vascular disorders Hypotension	16.7% 6/36 • Number of events 6 • First transplant until end of study (up to 9 years post first transplant) This study graded the severity of adverse events experienced by the study participant according to criteria set forth in the National Cancer Institute's Common Toxicity Criteria Version 2.0 (April 30, 1999)

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