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Pilot Study of Leuprolide to Improve Immune Function After Allogeneic Bone Marrow Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01338987
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : April 23, 2019
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
Christopher Kanakry, M.D., National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myelodysplastic Syndrome
Acute Lymphocytic Leukemia
Acute Myelogenous Leukemia
Chronic Myelogenous Leukemia
Chronic Myelomonocytic Leukemia
Interventions Procedure: First Allogeneic Bone Marrow Transplant (BMT)
Drug: Leuprolide
Drug: 18F FLT
Drug: Cyclophosphamide
Drug: Methotrexate
Drug: Tacrolimus
Radiation: Total Body Irradiation
Drug: Busulfan
Drug: Fludarabine
Procedure: Second Allogeneic Bone Marrow Transplantation
Enrollment 76
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Males That Did Not Receive Leuprolide for 1st Transplant Males Randomized to Receive Leuprolide for 1st Transplant Females That Received Leuprolide for 1st Transplant Matched Related Donors for Transplant Recipients of 2nd Transplant
Hide Arm/Group Description Males undergoing first transplant who did not receive leuprolide. Males undergoing first transplant who were randomized to receive leuprolide. Females undergoing first transplant who all received leuprolide. Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study. Patients receiving second allogeneic bone marrow transplant on this study.
Period Title: Overall Study
Started 12 9 22 31 2
Completed 10 8 20 31 2
Not Completed 2 1 2 0 0
Reason Not Completed
enrolled on new protocol             0             0             1             0             0
Disease progression on study             2             1             1             0             0
Arm/Group Title Males That Did Not Receive Leuprolide for 1st Transplant Males Randomized to Receive Leuprolide for 1st Transplant Females That Received Leuprolide for 1st Transplant Matched Related Donors for Transplant Recipients of 2nd Transplant Total
Hide Arm/Group Description Males undergoing first transplant who did not receive leuprolide. Males undergoing first transplant who were randomized to receive leuprolide. Females undergoing first transplant who all received leuprolide. Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study. Patients receiving second allogeneic Bone Marrow Transplant on this study. Total of all reporting groups
Overall Number of Baseline Participants 12 9 22 31 2 76
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 9 participants 22 participants 31 participants 2 participants 76 participants
<=18 years
1
   8.3%
0
   0.0%
0
   0.0%
3
   9.7%
0
   0.0%
4
   5.3%
Between 18 and 65 years
11
  91.7%
9
 100.0%
22
 100.0%
28
  90.3%
2
 100.0%
72
  94.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 9 participants 22 participants 31 participants 2 participants 76 participants
33  (9.30) 26.77  (5.71) 36.05  (6.10) 33.86  (11.49) 23.05  (3.61) 33.61  (10.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 9 participants 22 participants 31 participants 2 participants 76 participants
Female
0
   0.0%
0
   0.0%
22
 100.0%
17
  54.8%
0
   0.0%
39
  51.3%
Male
12
 100.0%
9
 100.0%
0
   0.0%
14
  45.2%
2
 100.0%
37
  48.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 9 participants 22 participants 31 participants 2 participants 76 participants
Hispanic or Latino
8
  66.7%
6
  66.7%
15
  68.2%
26
  83.9%
1
  50.0%
56
  73.7%
Not Hispanic or Latino
4
  33.3%
3
  33.3%
7
  31.8%
5
  16.1%
1
  50.0%
20
  26.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 9 participants 22 participants 31 participants 2 participants 76 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   4.5%
1
   3.2%
0
   0.0%
2
   2.6%
Asian
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  16.7%
1
  11.1%
3
  13.6%
2
   6.5%
0
   0.0%
8
  10.5%
White
9
  75.0%
5
  55.6%
15
  68.2%
28
  90.3%
2
 100.0%
59
  77.6%
More than one race
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.3%
Unknown or Not Reported
0
   0.0%
2
  22.2%
3
  13.6%
0
   0.0%
0
   0.0%
5
   6.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 9 participants 22 participants 31 participants 2 participants 76 participants
12
 100.0%
9
 100.0%
22
 100.0%
31
 100.0%
2
 100.0%
76
 100.0%
1.Primary Outcome
Title Percentage of B Cells at One Year Post-transplant in Participants Who Did/Did Not Receive Leuprolide Following Bone Marrow Transplant (BMT)
Hide Description B cell percentage is defined as the percentage of lymphocytes that are B cells.
Time Frame after first Bone Marrow Transplant, approximately 12 months post-transplant
Hide Outcome Measure Data
Hide Analysis Population Description
Only first BMT patients (SG1-3) with >1 year of follow-up without relapse were evaluable. Of evaluable patients, 5 males and 9 females received and 7 males did not receive Lupron. Reasons for patients being inevaluable were missing data (2) or insufficient follow-up due to death without relapse (3), relapse (11), or withdrawal (1) before 1 year.
Arm/Group Title Transplant Recipient
Hide Arm/Group Description:
Patients receiving first allogeneic bone marrow transplant on this study.
Overall Number of Participants Analyzed 21
Median (Full Range)
Unit of Measure: percentage of cells
Males that received leuprolide Number Analyzed 5 participants
22.1
(2.2 to 30.7)
Males that did not receive leuprolide Number Analyzed 7 participants
21.9
(0.2 to 32.5)
Females who all received leuprolide Number Analyzed 9 participants
14.3
(2.1 to 50.5)
2.Primary Outcome
Title Time to Engraftment in First Transplant Recipients Only With Median Thoracic Spine Standardized Uptake Values (SUV) of 1.4 or Greater Than Those Patients With SUV's Less Than 1.4
Hide Description 18F-FLT imaging was performed serially on patients post transplant to identify the level of uptake of 18F-FLT at a day +5 to +12 scan and the day at which neutrophils recover to >500 (i.e., subclinical bone-marrow recovery within 5 days of Bone Marrow Transplantation (BMT infusion)). On each image for each patient, the region of interest was drawn within each thoracic medullary space (n=12), generating the SUV for each space. The mean of these was calculated for each scan. The analysis was the median of the means of the SUV of the thorax values of the day 5-12 scan (averaged the SUV of the thorax for each patient and then took the medians of these).
Time Frame 18F FLT scan done between days +5 to +12 and then time from that scan to engraftment measured
Hide Outcome Measure Data
Hide Analysis Population Description
The pre-specified cohort for this endpoint was 23 first BMT recipients. Only 20 of 23 were evaluable due to inability to obtain the early scan (1) or early relapse (2). As pre-specified in the protocol, all 20 patients were analyzed together as the intention was to look at the imaging modality itself and not any effect of leuprolide.
Arm/Group Title Transplant Recipient
Hide Arm/Group Description:
Patients receiving first allogeneic bone marrow transplant on this study.
Overall Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: Days
Patients with SUV 1.4 or greater Number Analyzed 5 participants
5
(3 to 13)
Patients with SUV less than 1.4 Number Analyzed 15 participants
15
(8 to 22)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Transplant Recipient
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments [Not Specified]
Method Wilcoxon's rank sum test
Comments [Not Specified]
3.Primary Outcome
Title Number of Adverse Events Related to Study Drug Experienced by Participants After Second Bone Marrow Transplant (BMT)
Hide Description Serious and non-serious adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame 12 months after second BMT
Hide Outcome Measure Data
Hide Analysis Population Description
Only the patients in the SG4 group who had a 2nd BMT had a primary endpoint of toxicity requiring leuprolide AE reporting.
Arm/Group Title Transplant Recipient - 2nd Bone Marrow Transplant
Hide Arm/Group Description:
Patients receiving second allogeneic bone marrow transplant on this study.
Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: Adverse Events
0
4.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)
Hide Description Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame Date treatment consent signed to date off study, approximately 79 months and 11 days.
Hide Outcome Measure Data
Hide Analysis Population Description
40/45 transplant recipients and all 31 donors were evaluable for adverse events as five patients did not proceed to transplant after enrollment due to progression of disease in four cases and enrollment on a new protocol in one case.
Arm/Group Title Males That Did Not Receive Leuprolide for 1st Transplant Males Randomized to Receive Leuprolide for 1st Transplant Females That Received Leuprolide for 1st Transplant Matched Related Donors for Transplant Recipients of 2nd Transplant
Hide Arm/Group Description:
Males undergoing first transplant who did not receive leuprolide.
Males undergoing first transplant who were randomized to receive leuprolide.
Females undergoing first transplant who all received leuprolide.
Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic Bone Marrow Transplant on this study.
Patients receiving second allogeneic Bone Marrow Transplant on this study.
Overall Number of Participants Analyzed 10 8 20 31 2
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
8
 100.0%
20
 100.0%
4
  12.9%
2
 100.0%
Time Frame Date treatment consent signed to date off study, approximately 79 months and 11 days.
Adverse Event Reporting Description 40/45 participants were evaluable for adverse events.
 
Arm/Group Title Males That Did Not Receive Leuprolide for 1st Transplant Males Randomized to Receive Leuprolide for 1st Transplant Females That Received Leuprolide for 1st Transplant Matched Related Donors for Transplant Recipients of 2nd Transplant
Hide Arm/Group Description Males undergoing first transplant who did not receive leuprolide. Males undergoing first transplant who were randomized to receive leuprolide. Females undergoing first transplant who all received leuprolide. Individuals related to patients and who gave hematopoietic stem cells for patients receiving allogeneic bone marrow transplant on this study. Patients receiving second allogeneic bone marrow transplant on this study.
All-Cause Mortality
Males That Did Not Receive Leuprolide for 1st Transplant Males Randomized to Receive Leuprolide for 1st Transplant Females That Received Leuprolide for 1st Transplant Matched Related Donors for Transplant Recipients of 2nd Transplant
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/10 (40.00%)      3/8 (37.50%)      8/20 (40.00%)      0/31 (0.00%)      2/2 (100.00%)    
Hide Serious Adverse Events
Males That Did Not Receive Leuprolide for 1st Transplant Males Randomized to Receive Leuprolide for 1st Transplant Females That Received Leuprolide for 1st Transplant Matched Related Donors for Transplant Recipients of 2nd Transplant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/10 (50.00%)      6/8 (75.00%)      15/20 (75.00%)      2/31 (6.45%)      2/2 (100.00%)    
Blood and lymphatic system disorders           
Disseminated intravascular coagulation  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Febrile neutropenia  1  2/10 (20.00%)  3 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Hemolysis  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Hemolytic uremic syndrome  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Cardiac disorders           
Pericardial effusion  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Sinus tachycardia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Eye disorders           
Cataract  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Corneal ulcer  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  1  1/10 (10.00%)  1 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Colitis  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Colonic perforation  1  0/10 (0.00%)  0 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Diarrhea  1  0/10 (0.00%)  0 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Gastric hemorrhage  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Oral hemorrhage  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Typhlitis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Upper gastrointestinal hemorrhage  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
General disorders           
Death NOS  1  1/10 (10.00%)  1 1/8 (12.50%)  1 3/20 (15.00%)  3 0/31 (0.00%)  0 0/2 (0.00%)  0
Multi-organ failure  1  0/10 (0.00%)  0 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Pain  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Hepatobiliary disorders           
Hepatic failure  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Immune system disorders           
Cytokine release syndrome  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations           
Catheter related infection  1  0/10 (0.00%)  0 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, E.coli (blood, lungs)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Fever, neutropenia  1  1/10 (10.00%)  1 0/8 (0.00%)  0 5/20 (25.00%)  8 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Influenza H1N1  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Kaposi's sarcoma (HHV8)  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, PCP Pneumonia  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Parainfluenza III  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Presumed fungal  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Pseudomonas bacter  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, RSV  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Stenotrophom maltophilia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Stenotrophomonas bacteremia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, adeno viremia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, presumed bacterial infection  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Candida glabrata in blood  1  0/10 (0.00%)  0 1/8 (12.50%)  2 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  2
Lung infection  1  0/10 (0.00%)  0 2/8 (25.00%)  3 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Meningitis  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Sepsis  1  0/10 (0.00%)  0 2/8 (25.00%)  2 4/20 (20.00%)  4 0/31 (0.00%)  0 0/2 (0.00%)  0
Sinusitis  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Upper respiratory infection  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Urinary tract infection  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and Infestations - Other, Candida glabrata in blood  1  0/10 (0.00%)  0 1/8 (12.50%)  2 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Investigations           
Alanine aminotransferase increased  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Blood bilirubin increased  1  0/10 (0.00%)  0 1/8 (12.50%)  2 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Metabolism and nutrition disorders           
Acidosis  1  1/10 (10.00%)  1 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 1/2 (50.00%)  1
Metabolism and nutrition disorders - Other, acidosis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Tumor lysis syndrome  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Neck pain  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders           
Syncope  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Psychiatric disorders           
Depression  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders           
Cystitis noninfective  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders - Other, renal failure  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Renal hemorrhage  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Adult respiratory distress syndrome  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Aspiration  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Dyspnea  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Hypoxia  1  0/10 (0.00%)  0 1/8 (12.50%)  1 3/20 (15.00%)  3 0/31 (0.00%)  0 0/2 (0.00%)  0
Pleural effusion  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Pneumonitis  1  0/10 (0.00%)  0 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Pneumothorax  1  0/10 (0.00%)  0 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 1/2 (50.00%)  1
Respiratory failure  1  1/10 (10.00%)  1 1/8 (12.50%)  2 4/20 (20.00%)  6 0/31 (0.00%)  0 2/2 (100.00%)  3
Vascular disorders           
Hypotension  1  0/10 (0.00%)  0 0/8 (0.00%)  0 5/20 (25.00%)  8 2/31 (6.45%)  2 0/2 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Males That Did Not Receive Leuprolide for 1st Transplant Males Randomized to Receive Leuprolide for 1st Transplant Females That Received Leuprolide for 1st Transplant Matched Related Donors for Transplant Recipients of 2nd Transplant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      8/8 (100.00%)      20/20 (100.00%)      4/31 (12.90%)      2/2 (100.00%)    
Blood and lymphatic system disorders           
Anemia  1  9/10 (90.00%)  28 5/8 (62.50%)  28 12/20 (60.00%)  39 3/31 (9.68%)  3 2/2 (100.00%)  4
Febrile neutropenia  1  2/10 (20.00%)  2 2/8 (25.00%)  3 7/20 (35.00%)  7 0/31 (0.00%)  0 1/2 (50.00%)  2
Cardiac disorders           
Atrial fibrillation  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Pericardial effusion  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Sinus bradycardia  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Sinus tachycardia  1  2/10 (20.00%)  2 1/8 (12.50%)  2 3/20 (15.00%)  3 0/31 (0.00%)  0 1/2 (50.00%)  2
Ear and labyrinth disorders           
Hearing impaired  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Otitis externa  1  1/10 (10.00%)  1 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Endocrine disorders           
Adrenal insufficiency  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Endocrine disorders - Other, Hypoganadism  1  1/10 (10.00%)  1 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Hypothyroidism  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Eye disorders           
Blurred vision  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Cataract  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Dry eye  1  1/10 (10.00%)  1 2/8 (25.00%)  2 4/20 (20.00%)  4 0/31 (0.00%)  0 0/2 (0.00%)  0
Keratitis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Retinal tear  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Gastrointestinal disorders           
Abdominal pain  1  1/10 (10.00%)  2 2/8 (25.00%)  3 6/20 (30.00%)  8 0/31 (0.00%)  0 1/2 (50.00%)  2
Ascites  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  2
Colitis  1  2/10 (20.00%)  2 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Colonic ulcer  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Constipation  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Diarrhea  1  4/10 (40.00%)  5 5/8 (62.50%)  6 10/20 (50.00%)  12 0/31 (0.00%)  0 2/2 (100.00%)  3
Dry mouth  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Dyspepsia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Enterocolitis  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Esophagitis  1  1/10 (10.00%)  2 1/8 (12.50%)  2 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Gastritis  1  0/10 (0.00%)  0 1/8 (12.50%)  1 2/20 (10.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Gastrointestinal disorders - Other, Melanotic Stool  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Gastroparesis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Ileal hemorrhage  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Mucositis oral  1  1/10 (10.00%)  1 3/8 (37.50%)  3 4/20 (20.00%)  4 0/31 (0.00%)  0 0/2 (0.00%)  0
Nausea  1  4/10 (40.00%)  6 1/8 (12.50%)  2 9/20 (45.00%)  13 0/31 (0.00%)  0 1/2 (50.00%)  1
Oral pain  1  3/10 (30.00%)  3 1/8 (12.50%)  3 4/20 (20.00%)  6 0/31 (0.00%)  0 1/2 (50.00%)  1
Rectal mucositis  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Small intestinal obstruction  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Typhlitis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 3/20 (15.00%)  3 0/31 (0.00%)  0 0/2 (0.00%)  0
Upper gastrointestinal hemorrhage  1  0/10 (0.00%)  0 0/8 (0.00%)  0 2/20 (10.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Vomiting  1  5/10 (50.00%)  5 1/8 (12.50%)  1 3/20 (15.00%)  3 0/31 (0.00%)  0 0/2 (0.00%)  0
General disorders           
Edema limbs  1  1/10 (10.00%)  1 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Fatigue  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Fever  1  4/10 (40.00%)  5 2/8 (25.00%)  5 6/20 (30.00%)  7 0/31 (0.00%)  0 1/2 (50.00%)  1
Hypothermia  1  0/10 (0.00%)  0 1/8 (12.50%)  2 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Pain  1  4/10 (40.00%)  5 2/8 (25.00%)  2 5/20 (25.00%)  5 0/31 (0.00%)  0 0/2 (0.00%)  0
Hepatobiliary disorders           
Cholecystitis  1  1/10 (10.00%)  1 0/8 (0.00%)  0 3/20 (15.00%)  4 0/31 (0.00%)  0 0/2 (0.00%)  0
Hepatobiliary disorders - Other, Hepatic steatosis  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Hepatobiliary disorders - Other, Ductal injury consistent w/GVHD, portal hypertension  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Hepatobiliary disorders - Other, acute liver injury  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Hepatobiliary disorders - Other, liver GVHD  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Immune system disorders           
Cytokine release syndrome  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations           
Catheter related infection  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Corneal infection  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, 6/24 Aeromonas infection of stool  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Adenoviremia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Ascaris lubricoides in stool  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, BK cystitis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, BK virus  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Blood cultures were positive for GPC/bacteremia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Blood cx: CMV+ ; CMV reactivation  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, C. diff  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, C. diff PCR+ 4/21  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, C. diff PCR+ 6/5  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV (blood)  1  2/10 (20.00%)  2 1/8 (12.50%)  1 2/20 (10.00%)  3 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV (blood, BAL, GI)  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV colitis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV reactivation  1  2/10 (20.00%)  2 0/8 (0.00%)  0 6/20 (30.00%)  6 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV reactivation (1600 copies)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV reactivation (blood)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV reactivation +6350 copies  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV reactivation and presumed CMV infection of GI.  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV viremia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV viremia, CMV gastritis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV-esophagitis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Coagulase-negative Staph, Rhinovirus/enterovirus  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Coronavirus  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Coronavirus 229E (nasal wash, upper respiratory)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, E.coli (UTI)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, EBV+PCR 3600 copies  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, ESBL Klebsiella urinary tract infection  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, ESBL bacteremia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Enteroaggregative E.coli (stool)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Enterococcus in blood  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Enteropathogenic E.coli (stool)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, GI tract  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Geotricum Capitatum  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Giardia  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, HHV6 (CSF)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, HSV oral ulcers  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Herpes zoster  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Human metapneumovirus  1  0/10 (0.00%)  0 0/8 (0.00%)  0 2/20 (10.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Hypotension  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Influenza B  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Klebsiela pneumonia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Klebsiella, serratia, stenotrophomonas  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Lymphadenitis (inguinal lymph node)  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Mumps  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, NP wash - rhinovirus  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Nocardia pulmonary infection  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, PICC, S.mitis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Pleseimonas shigelloides (stool)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Presumed fungal - BAL (pulmonary)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Pseudomonas aeruginosa (skin lesion)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, RSV  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Rhino/enterovirus  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Rhinovirus/enterovirus (NP wash)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Rotavirus  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Rothia (Stomatococcus) mucilaginosus;  1 [1]  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, STAPH EPI from CSF  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Shiga-like E.coli (SREC)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Staph epi, Enterococcus faecalis in blood  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Staph. Capitis product infection  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, THRUSH  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, VRE bacteremia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, VZV  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, VZV zoster  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Vancomycin-resistant Enterococcus  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Varicella zoster (back, abdomen)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Varicella zoster- L thoracic area  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, adenovirus  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, adenovirus viremia  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, bacterial vaginosis and C.albicans  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, bronchscopy - aspergillus  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, clostridium tertium  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, coronaviral URI (intermittent)  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, fungal (yeast in blood)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, lung microbiology  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, norovirus  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, oral candidiasis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, pneumonia-unknown organism  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, presumed BK virus  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, presumed bacterial  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, presumed fungal pneumonia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, presumed pneumonia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, presumed pneumonia, yeast infection  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, presumed viral  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, rhinovirus/enterovirus  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, staph aureus (sinusitis)  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, Clostridium difficile - stool  1  2/10 (20.00%)  2 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 1/2 (50.00%)  1
Infections and infestations - Other, HHV-6 (alveolar inf.)  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Infections and infestations - Other, Human rhinovirus/enterovirus  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Infections and infestations - Other, Staph epidermitis in blood (port inf.)  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Infections and infestations - Other, intermittent bacteremia  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Lung infection  1  5/10 (50.00%)  7 3/8 (37.50%)  4 5/20 (25.00%)  7 0/31 (0.00%)  0 1/2 (50.00%)  1
Meningitis  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Sepsis  1  1/10 (10.00%)  1 2/8 (25.00%)  2 2/20 (10.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Sinusitis  1  1/10 (10.00%)  1 1/8 (12.50%)  1 4/20 (20.00%)  4 0/31 (0.00%)  0 0/2 (0.00%)  0
Soft tissue infection  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Urinary tract infection  1  1/10 (10.00%)  1 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Vaginal infection  1  0/10 (0.00%)  0 0/8 (0.00%)  0 3/20 (15.00%)  5 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, pneumonia, presumed fungal  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, BK virus (urine infection)  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, CMV  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, staph aureus (sinusitis)  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Infections and infestations - Other, E. coli  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Injury, poisoning and procedural complications           
Fracture  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Injury, poisoning and procedural complications - Other, specify  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Stomal ulcer  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Investigations           
Activated partial thromboplastin time prolonged  1  2/10 (20.00%)  2 4/8 (50.00%)  4 6/20 (30.00%)  10 0/31 (0.00%)  0 1/2 (50.00%)  3
Alanine aminotransferase increased  1  6/10 (60.00%)  24 4/8 (50.00%)  8 14/20 (70.00%)  45 0/31 (0.00%)  0 1/2 (50.00%)  3
Alkaline phosphatase increased  1  3/10 (30.00%)  3 1/8 (12.50%)  6 5/20 (25.00%)  6 0/31 (0.00%)  0 1/2 (50.00%)  1
Aspartate aminotransferase increased  1  5/10 (50.00%)  14 3/8 (37.50%)  5 13/20 (65.00%)  36 0/31 (0.00%)  0 0/2 (0.00%)  0
Blood bilirubin increased  1  3/10 (30.00%)  4 2/8 (25.00%)  2 5/20 (25.00%)  10 0/31 (0.00%)  0 1/2 (50.00%)  2
CPK increased  1  1/10 (10.00%)  2 2/8 (25.00%)  3 1/20 (5.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Carbon monoxide diffusing capacity decreased  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Creatinine increased  1  1/10 (10.00%)  2 2/8 (25.00%)  2 5/20 (25.00%)  7 0/31 (0.00%)  0 1/2 (50.00%)  1
Ejection fraction decreased  1  1/10 (10.00%)  1 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Electrocardiogram QT corrected interval prolonged  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Fibrinogen decreased  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Lipase increased  1  1/10 (10.00%)  1 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Neutrophil count decreased  1  10/10 (100.00%)  49 7/8 (87.50%)  32 15/20 (75.00%)  83 0/31 (0.00%)  0 2/2 (100.00%)  2
Platelet count decreased  1  10/10 (100.00%)  43 7/8 (87.50%)  53 14/20 (70.00%)  49 0/31 (0.00%)  0 2/2 (100.00%)  6
Serum amylase increased  1  0/10 (0.00%)  0 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 1/2 (50.00%)  1
Weight gain  1  0/10 (0.00%)  0 0/8 (0.00%)  0 3/20 (15.00%)  3 0/31 (0.00%)  0 0/2 (0.00%)  0
Weight loss  1  0/10 (0.00%)  0 1/8 (12.50%)  2 2/20 (10.00%)  5 0/31 (0.00%)  0 0/2 (0.00%)  0
White blood cell decreased  1  10/10 (100.00%)  33 4/8 (50.00%)  46 16/20 (80.00%)  56 0/31 (0.00%)  0 2/2 (100.00%)  6
Metabolism and nutrition disorders           
Acidosis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Alkalosis  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Anorexia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 2/20 (10.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Hypercalcemia  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Hyperglycemia  1  3/10 (30.00%)  12 1/8 (12.50%)  1 5/20 (25.00%)  8 0/31 (0.00%)  0 0/2 (0.00%)  0
Hyperkalemia  1  1/10 (10.00%)  1 2/8 (25.00%)  2 3/20 (15.00%)  4 0/31 (0.00%)  0 1/2 (50.00%)  1
Hypermagnesemia  1  2/10 (20.00%)  4 1/8 (12.50%)  1 8/20 (40.00%)  9 0/31 (0.00%)  0 1/2 (50.00%)  1
Hypernatremia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Hypertriglyceridemia  1  1/10 (10.00%)  2 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Hyperuricemia  1  0/10 (0.00%)  0 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Hypoalbuminemia  1  2/10 (20.00%)  3 1/8 (12.50%)  4 8/20 (40.00%)  9 0/31 (0.00%)  0 2/2 (100.00%)  2
Hypocalcemia  1  1/10 (10.00%)  1 3/8 (37.50%)  3 4/20 (20.00%)  5 0/31 (0.00%)  0 1/2 (50.00%)  1
Hypokalemia  1  6/10 (60.00%)  17 3/8 (37.50%)  5 10/20 (50.00%)  13 0/31 (0.00%)  0 1/2 (50.00%)  1
Hypomagnesemia  1  2/10 (20.00%)  3 1/8 (12.50%)  1 4/20 (20.00%)  5 0/31 (0.00%)  0 1/2 (50.00%)  1
Hyponatremia  1  2/10 (20.00%)  2 2/8 (25.00%)  2 3/20 (15.00%)  3 0/31 (0.00%)  0 2/2 (100.00%)  2
Hypophosphatemia  1  8/10 (80.00%)  15 4/8 (50.00%)  6 12/20 (60.00%)  21 0/31 (0.00%)  0 2/2 (100.00%)  3
Metabolism and nutrition disorders - Other, specify  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders           
Avascular necrosis  1  1/10 (10.00%)  1 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 1/2 (50.00%)  1
Back pain  1  0/10 (0.00%)  0 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Muscle weakness lower limb  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorder - Other, Pain, bilateral shins/ankles R>L  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Myalgia  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Myositis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Neck pain  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Osteoporosis  1  1/10 (10.00%)  1 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Pain in extremity  1  1/10 (10.00%)  1 1/8 (12.50%)  1 3/20 (15.00%)  3 0/31 (0.00%)  0 0/2 (0.00%)  0
Nervous system disorders           
Cognitive disturbance  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Encephalopathy  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Headache  1  2/10 (20.00%)  2 1/8 (12.50%)  1 2/20 (10.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Peripheral sensory neuropathy  1  0/10 (0.00%)  0 0/8 (0.00%)  0 2/20 (10.00%)  2 1/31 (3.23%)  1 0/2 (0.00%)  0
Psychiatric disorders           
Agitation  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Anxiety  1  1/10 (10.00%)  1 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Confusion  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Delirium  1  1/10 (10.00%)  1 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Depression  1  2/10 (20.00%)  2 0/8 (0.00%)  0 2/20 (10.00%)  4 0/31 (0.00%)  0 1/2 (50.00%)  1
Hallucinations  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Insomnia  1  2/10 (20.00%)  2 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Psychiatric disorders - Other, acute mental status changes  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders           
Acute kidney injury  1  1/10 (10.00%)  1 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Hematuria  1  1/10 (10.00%)  1 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Proteinuria  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders - Other, renal insufficiency  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Urinary urgency  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Renal and urinary disorders - Other, membranous nephropathy  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Reproductive system and breast disorders           
Penile pain  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Reproductive system and breast disorders - Other, Dyspareunia, Vaginal dryness  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Reproductive system and breast disorders - Other, Vaginal bleeding  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Reproductive system and breast disorders - Other, vaginal scarring and stenosis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Allergic rhinitis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Aspiration  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Bronchopulmonary hemorrhage  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Cough  1  1/10 (10.00%)  2 1/8 (12.50%)  1 3/20 (15.00%)  3 0/31 (0.00%)  0 0/2 (0.00%)  0
Dyspnea  1  1/10 (10.00%)  2 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  2
Epistaxis  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Hypoxia  1  1/10 (10.00%)  2 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Pleural effusion  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Pneumonitis  1  1/10 (10.00%)  1 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Pneumothorax  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Upper respiratory infection  1  1/10 (10.00%)  3 1/8 (12.50%)  1 1/20 (5.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders           
Dry skin  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrome  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Papulopustular rash  1  1/10 (10.00%)  1 1/8 (12.50%)  1 3/20 (15.00%)  3 0/31 (0.00%)  0 0/2 (0.00%)  0
Rash acneiform  1  3/10 (30.00%)  6 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Rash maculo-papular  1  3/10 (30.00%)  5 3/8 (37.50%)  3 5/20 (25.00%)  5 0/31 (0.00%)  0 1/2 (50.00%)  1
Skin and subcutaneous tissue disorders - Other, Porokeratosis - buttocks  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, cGVHD, scleroderma, rash  1  1/10 (10.00%)  1 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, pimple-llike lesions neck, fase, chest  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, rash  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Skin ulceration  1  2/10 (20.00%)  3 0/8 (0.00%)  0 0/20 (0.00%)  0 0/31 (0.00%)  0 0/2 (0.00%)  0
Vascular disorders           
Capillary leak syndrome  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Hot flashes  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  2 0/31 (0.00%)  0 0/2 (0.00%)  0
Hypertension  1  0/10 (0.00%)  0 1/8 (12.50%)  2 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Hypotension  1  0/10 (0.00%)  0 1/8 (12.50%)  1 1/20 (5.00%)  1 0/31 (0.00%)  0 1/2 (50.00%)  1
Phlebitis  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
Thromboembolic event  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Vascular disorders - Other, Anasarca B/L  1  0/10 (0.00%)  0 1/8 (12.50%)  1 0/20 (0.00%)  0 0/31 (0.00%)  0 1/2 (50.00%)  1
Vascular disorders - Other, TAM-transfusion associated microangiopathy  1  0/10 (0.00%)  0 0/8 (0.00%)  0 1/20 (5.00%)  1 0/31 (0.00%)  0 0/2 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
1/2 bottles with GPC in pairs & chains
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christopher Kanakry
Organization: National Cancer Institute
Phone: 240-760-6171
EMail: christopher.kanakry@nih.gov
Layout table for additonal information
Responsible Party: Christopher Kanakry, M.D., National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01338987    
Other Study ID Numbers: 110136
11-C-0136
First Submitted: April 19, 2011
First Posted: April 20, 2011
Results First Submitted: November 30, 2018
Results First Posted: April 23, 2019
Last Update Posted: March 18, 2021