Donor Peripheral Stem Cell Transplant in Treating Patient... | NCT00544115 | Trialant
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Studies Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders NCT00544115 Show options City of Hope Medical Center
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition busulfan cyclophosphamide cyclosporine etoposide fludarabine phosphate melphalan methotrexate mycophenolate mofetil sirolimus tacrolimus allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation Obsolete or Duplicate NCT IDs Not provided
ID Type Description Link P30CA033572 U.S. NIH Grant/Contract CHNMC-01089 01089 CDR0000566376 Registry Identifier NCI PDQ
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders
A Phase II Trial of Allogeneic Peripheral Blood Stem Cell Transplantation From Matched Unrelated Donors in Patients With Advanced Hematologic Malignancies and Hematological Disorders
City of Hope Medical Center OTHER
Overall Recruitment Status or Expanded Access Status Active, not recruiting
First Submission Date that Met QC Criteria Oct 13, 2007
Results First Submitted Date Mar 9, 2023
Results First Submitted that Met QC Criteria Apr 18, 2023
Results First Posted Date May 10, 2023 Actual
Certification/Extension (aka Delayed Results) First Submitted Date Not provided
Certification/Extension First Submitted that Passed QC Review Not provided
Certification/Extension First Posted Date Not provided
Last Update Submitted Date May 7, 2026
Responsible Party, by Official Title Sponsor
City of Hope Medical Center OTHER
Name Class National Cancer Institute (NCI) NIH
No data available
No data is available for this block.
RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus, methotrexate, cyclosporine, mycophenolate mofetil, and sirolimus before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well donor peripheral stem cell transplant works in treating patients with advanced hematologic cancer or other disorders.
OBJECTIVES:
Primary
To evaluate hematopoietic recovery, using neutrophil and platelet engraftment as the primary criterion, in patients with advanced hematologic malignancies or other disorders undergoing allogeneic peripheral blood stem cell (PBSC) transplantation from matched unrelated donors.
To evaluate the incidence of acute and chronic graft-versus-host-disease (GVHD) in patients undergoing allogeneic PBSC transplantation from matched unrelated donors.
Secondary
To evaluate the impact of HLA class I and class II allele-matching on the incidence of GVHD and on the survival outcome of these patients.
To evaluate overall survival, disease-free survival, and relapse in these patients.
OUTLINE: Patients are stratified according to type of conditioning regimen (myeloablative vs reduced-intensity myeloablative). Patients are assigned to a conditioning regimen according to diagnosis, age, disease status, prior radiotherapy, and prior autologous stem cell transplantation.
Conditioning regimen:
Regimen I: Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
Regimen II: Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
Regimen III: Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
Regimen IV: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
Regimen V: Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
Regimen VI: Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.
Allogeneic peripheral blood stem cell (PBSC) transplantation: All patients undergo allogeneic PBSC transplantation on day 0.
Graft-versus-host disease (GVHD) prophylaxis: Patients receive one of the following GVHD prophylaxis regimens:
Regimen A: Patients receive tacrolimus IV or orally on days -1 to 180 and methotrexate IV on days 1, 3, 6, and 11.
Regimen B: Patients receive cyclosporine IV or orally twice daily on days -1 to 180, mycophenolate mofetil IV over 2 hours or orally twice daily on days 0-27, and methotrexate IV on days 1, 3, and 6.
Regimen C: Patients receive tacrolimus IV continuously or orally, and oral sirolimus beginning on day -3. Patients also receive methotrexate IV on days 1, 3, and 6.
After completion of study therapy, patients are followed periodically.
Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Precancerous/Nonmalignant Condition graft versus host disease recurrent adult acute lymphoblastic leukemia recurrent childhood acute lymphoblastic leukemia untreated adult acute lymphoblastic leukemia untreated childhood acute lymphoblastic leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes refractory anemia with excess blasts in transformation refractory anemia with excess blasts atypical chronic myeloid leukemia chronic myelomonocytic leukemia juvenile myelomonocytic leukemia myelodysplastic/myeloproliferative disease, unclassifiable recurrent adult acute myeloid leukemia Number of References to an Expanded Access Study Not provided
Target Follow-Up Duration Not provided
No data available
No data is available for this block.
Label Type Description Intervention Names Regimen I Active Comparator Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Drug: mycophenolate mofetil Drug: sirolimus Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: total-body irradiation Regimen II Active Comparator Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Drug: mycophenolate mofetil Drug: sirolimus Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Regimen III Active Comparator Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
Drug: cyclosporine Drug: etoposide Drug: methotrexate Drug: mycophenolate mofetil Drug: sirolimus Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: total-body irradiation
Name Type Description Arm Group Labels Other Names busulfan Drug cyclophosphamide
Measure Description Time Frame Neutrophil Engraftment - The Days Till ANC Recovery The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is > 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment.
Up to 180 days post transplant
Measure Description Time Frame Two-year Overall Survival Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 2 years after transplant and Kaplan-Meier survival analysis was used to generate the two-year Overall Survival estimate presented.
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
Acute lymphocytic leukemia (ALL), meeting one of the following criteria:
Acute myeloid leukemia (AML), meeting one of the following criteria:
In first complete remission
Failed to achieve remission
In first relapse or beyond
Secondary AML (> 30% blasts in marrow aspirate)
Should receive induction chemotherapy to obtain remission, if possible, before transplant
Chronic myelogenous leukemia, meeting one of the following criteria:
In first or second chronic phase or accelerated phase
In blast crisis, defined as > 30% promyelocytes plus blasts in the bone marrow
Myelodysplastic syndromes, including any of the following:
Refractory anemia with excess blasts (RAEB)
Chronic myelomonocytic leukemia
RAEB in transformation
Refractory non-Hodgkin lymphoma, chronic lymphocytic leukemia, Hodgkin lymphoma, or multiple myeloma
Received and failed front-line therapy, high-dose therapy and autologous stem cell transplantation, or salvage therapy
Myeloproliferative disorders/myelofibrosis may be allowed on a case by case basis
Severe aplastic anemia, paroxysmal nocturnal hemoglobinuria, or any other hematologic disorder requiring transplantation
Patients > 55 years of age with hematologic diseases treatable by allogeneic stem cell transplantation who are not eligible for IRB 99190 are eligible
No uncontrolled CNS involvement of disease
No matched (6/6) related donor available
HLA-identical unrelated donor available
PATIENT CHARACTERISTICS:
Karnofsky performance status 50-100%
Life expectancy > 8 weeks
LVEF ≥ 45% at rest
AST ≤ 2 times normal (unless liver function abnormality is due to underlying disease)
Total bilirubin < 1.5 times normal (unless liver function abnormality is due to underlying disease)
Creatinine ≤ 1.5 times normal OR creatinine clearance ≥ 60 mL/min
DLCO ≥ 40% of predicted (corrected for hemoglobin)
No coexisting medical problem that would significantly increase the risk of the transplant procedure
HIV negative
Not pregnant
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Accepts Healthy Volunteers No
Name Affiliation Role Auayporn P. Nademanee, MD City of Hope Medical Center Study Chair
No data available
No data is available for this block.
No data available
No data is available for this block.
Among the 260 enrolled patients, who consented to the study, 5 patients were not eligible.
ID Title Description FG000 Regimen I Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
cyclophosphamide
cyclosporine
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
Title Milestones Reasons Not Completed Overall Study Type Comment Milestone Data STARTED
Baseline Analysis Population Description Not provided
No data available
No data is available for this block.
Document Has No Statistical Analysis Plan (SAP) Not provided
Uploaded Document Information Type Includes Protocol Includes SAP Includes ICF Document Label Document Date Document Uploaded Date Document File Name Prot_SAP Yes Yes No Study Protocol and Statistical Analysis Plan Jan 13, 2020
No data available
No data is available for this block.
recurrent childhood acute myeloid leukemia
adult acute myeloid leukemia in remission
childhood acute myeloid leukemia in remission
secondary acute myeloid leukemia
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
accelerated phase chronic myelogenous leukemia
blastic phase chronic myelogenous leukemia
childhood chronic myelogenous leukemia
chronic phase chronic myelogenous leukemia
relapsing chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic neutrophilic leukemia
essential thrombocythemia
polycythemia vera
Waldenstrom macroglobulinemia
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
nodal marginal zone B-cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent marginal zone lymphoma
recurrent small lymphocytic lymphoma
splenic marginal zone lymphoma
recurrent childhood grade III lymphomatoid granulomatosis
childhood nasal type extranodal NK/T-cell lymphoma
recurrent childhood large cell lymphoma
childhood diffuse large cell lymphoma
childhood immunoblastic large cell lymphoma
recurrent childhood lymphoblastic lymphoma
Burkitt lymphoma
recurrent childhood small noncleaved cell lymphoma
anaplastic large cell lymphoma
angioimmunoblastic T-cell lymphoma
recurrent adult T-cell leukemia/lymphoma
recurrent adult grade III lymphomatoid granulomatosis
adult nasal type extranodal NK/T-cell lymphoma
recurrent adult Hodgkin lymphoma
recurrent/refractory childhood Hodgkin lymphoma
refractory chronic lymphocytic leukemia
refractory multiple myeloma
stage III multiple myeloma
aplastic anemia
paroxysmal nocturnal hemoglobinuria
adult acute lymphoblastic leukemia in remission
childhood acute lymphoblastic leukemia in remission
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent mycosis fungoides/Sezary syndrome
stage II multiple myeloma Non-Randomized
Intervention Model Description Not provided
Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
Drug: cyclosporine Drug: fludarabine phosphate Drug: melphalan Drug: methotrexate Drug: mycophenolate mofetil Drug: sirolimus Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation
Regimen V Active Comparator Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
Drug: cyclosporine Drug: fludarabine phosphate Drug: methotrexate Drug: mycophenolate mofetil Drug: sirolimus Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: total-body irradiation
Regimen VI Active Comparator Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.
Drug: busulfan Drug: cyclosporine Drug: fludarabine phosphate Drug: methotrexate Drug: mycophenolate mofetil Drug: sirolimus Drug: tacrolimus Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation
Drug
cyclosporine Drug Regimen I Regimen II Regimen III Regimen IV Regimen V Regimen VI
fludarabine phosphate Drug Regimen IV Regimen V Regimen VI
methotrexate Drug Regimen I Regimen II Regimen III Regimen IV Regimen V Regimen VI
mycophenolate mofetil Drug Regimen I Regimen II Regimen III Regimen IV Regimen V Regimen VI
sirolimus Drug Regimen I Regimen II Regimen III Regimen IV Regimen V Regimen VI
tacrolimus Drug Regimen I Regimen II Regimen III Regimen IV Regimen V Regimen VI
allogeneic hematopoietic stem cell transplantation Procedure Regimen I Regimen II Regimen III Regimen IV Regimen V Regimen VI
peripheral blood stem cell transplantation Procedure Regimen I Regimen II Regimen III Regimen IV Regimen V Regimen VI
total-body irradiation Radiation Regimen I Regimen III Regimen V
Up to 2 years post transplant
FG001 Regimen II Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
busulfan
cyclophosphamide
cyclosporine
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
FG002 Regimen III Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
cyclosporine
etoposide
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
FG003 Regimen IV Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
cyclosporine
fludarabine phosphate
melphalan
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
FG004 Regimen V Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
cyclosporine
fludarabine phosphate
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
FG005 Regimen VI Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.
busulfan
cyclosporine
fludarabine phosphate
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
FG000 62 subjects
FG001 17 subjects
FG002 130 subjects
FG003 4 subjects
FG004 40 subjects
FG005 2 subjects COMPLETED FG000 62 subjects FG001 17 subjects FG002 130 subjects FG003 4 subjects FG004 40 subjects FG005 2 subjects
NOT COMPLETED FG000 0 subjects FG001 0 subjects FG002 0 subjects FG003 0 subjects FG004 0 subjects FG005 0 subjects
Type of Units Analyzed
ID Title Description BG000 Regimen I Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
cyclophosphamide
cyclosporine
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
BG001 Regimen II Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
busulfan
cyclophosphamide
cyclosporine
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
BG002 Regimen III Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
cyclosporine
etoposide
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
BG003 Regimen IV Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
cyclosporine
fludarabine phosphate
melphalan
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
BG004 Regimen V Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
cyclosporine
fludarabine phosphate
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
BG005 Regimen VI Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.
busulfan
cyclosporine
fludarabine phosphate
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
BG006 Total Total of all reporting groups
Units Counts Participants BG000 62 BG001 17 BG002 130 BG003 4 BG004 40 BG005 2 BG006 255
Title Description Population Description Parameter Type Dispersion Type Unit of Measure Calculate Percentage Denominator Units Selected Denominators Classes Age, Continuous Median Full Range years Title Denominators Categories Title Measurements BG000 38 (14 to 62) BG001 52 (12 to 62) BG002 50 (6 to 67) BG003
Sex: Female, Male Count of Participants Participants Title Denominators Categories
Race (NIH/OMB) Count of Participants Participants Title Denominators Categories Title Measurements American Indian or Alaska Native
Region of Enrollment Number participants Title Denominators Categories United States
Type Title Description Population Description Reporting Status Anticipated Posting Date Parameter Type Dispersion Type Unit of Measure Calculate Percentage Time Frame Units Analyzed Denominator Units Selected Arm/Group Information Denominators Classes Analyses Primary Neutrophil Engraftment - The Days Till ANC Recovery The primary engraftment endpoint, neutrophil engraftment, is defined as the first of three consecutive days on which the absolute neutrophil count is > 500/µL. The duration and extent of neutrophil engraftment is the time from transplant to neutrophil engraftment.
Some patients had engraftment failure and some had missing data. Therefore, the overall number of participants analyzed in each regimen is less than the overall number in the Participant Flow module.
Posted Median 95% Confidence Interval days Up to 180 days post transplant ID Title Description OG000 Regimen I Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
cyclophosphamide
cyclosporine
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
OG001 Regimen II Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
busulfan
cyclophosphamide
cyclosporine
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
OG002 Regimen III Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
cyclosporine
etoposide
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
OG003 Regimen IV Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
cyclosporine
fludarabine phosphate
melphalan
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
OG004 Regimen V Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
cyclosporine
fludarabine phosphate
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
OG005 Regimen VI Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.
busulfan
cyclosporine
fludarabine phosphate
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
Units Counts Participants OG000 42 OG001 13 OG002 113 OG003
Title Denominators Categories Title Measurements OG000 17 (11 to 39) OG001 16 (13 to 21) OG002 15 (8 to 36) OG003
Secondary Two-year Overall Survival Overall survival (OS) was measured from peripheral stem cell infusion to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula. Participants were followed up to 2 years after transplant and Kaplan-Meier survival analysis was used to generate the two-year Overall Survival estimate presented.
1 subject in Regimen II did not have transplant.
Posted Number 95% Confidence Interval percentage of survival probability Up to 2 years post transplant ID Title Description OG000 Regimen I Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
cyclophosphamide
cyclosporine
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
OG001 Regimen II Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
busulfan
cyclophosphamide
cyclosporine
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
Adverse events were assessed up to Day 100 post-transplant. All-Cause Mortality was assessed from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 20 years.
All-Cause Mortality Comment Not provided
ID Title Description Deaths (Affected) Deaths (At Risk) Serious Events (Affected) Serious Events (At Risk) Other Events (Affected) Other Events (At Risk) EG000 Regimen I Patients undergo total body irradiation (TBI) on days -7 to -4 and receive cyclophosphamide IV on days -3 and -2. Alternatively, patients may receive cyclophosphamide on days -7 and -6 and undergo TBI on days -4 to -1.
cyclophosphamide
cyclosporine
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
45 62 4 62 14 62 EG001 Regimen II Patients receive busulfan IV over 2 hours once on day -8 and then every 6 hours on days -7 to -4. Patients also receive cyclophosphamide IV on days -3 and -2.
busulfan
cyclophosphamide
cyclosporine
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
14 17 1 17 4 17 EG002 Regimen III Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
cyclosporine
etoposide
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
103 130 7 130 38 130 EG003 Regimen IV Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
cyclosporine
fludarabine phosphate
melphalan
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
2 4 0 4 0 4 EG004 Regimen V Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
cyclosporine
fludarabine phosphate
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
32 40 3 40 10 40 EG005 Regimen VI Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.
busulfan
cyclosporine
fludarabine phosphate
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
1 2 1 2 1 2
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Coagulation - Other (Specify, __) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 0 events 0 affected 4 at risk EG004 Hemorrhage/Bleeding - Other (Specify, __) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Hemorrhage/bleeding associated with surgery, intra-operative or postoperative Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Melena/GI bleeding Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Platelets Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Platelets for BMT studies, if specified in the protocol. Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Portal vein flow Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Thrombotic microangiopathy for BMT studies, if specified by the protocol. Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Cardiac General - Other (Specify, __) Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Cardiac troponin I (cTnI) Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Edema Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Hypertension Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Hypotension Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Pericardial effusion (non-malignant) Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Supraventricular and nodal arrhythmia Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Ventricular arrhythmia Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Anorexia Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Colitis Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Diarrhea Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Diarrhea associated with GVHD for BMT studies, if specified in the protocol. Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Mucositis/stomatitis (functional/symptomatic) Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Nausea Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol. Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Fatigue (asthenia, lethargy, malaise) General disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Pain General disorders MedDRA (9.0) Systematic Assessment EG000 2 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Pain - Other (Specify, __) General disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Weight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified in the protocol. General disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Bilirubin associated with GVHD for BMT studies, if specified in the protocol. Hepatobiliary disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Liver dysfunction/failure (clinical) Hepatobiliary disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Infection with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Infection - Other (Specify, __) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 1 affected 130 at risk EG003 Infection with unknown ANC Infections and infestations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Infection without neutropenia Infections and infestations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Infection, Bacterial (COH) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Infection, Viral (COH) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 ALT, SGPT (serum glutamic pyruvic transaminase) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 AST, SGOT(serum glutamic oxaloacetic transaminase) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Albumin, serum-low (hypoalbuminemia) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Alkalosis (metabolic or respiratory) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Bilirubin (hyperbilirubinemia) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Calcium, serum-low (hypocalcemia) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Creatinine Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Glucose, serum-high (hyperglycemia) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Phosphate, serum-low (hypophosphatemia) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Potassium, serum-low (hypokalemia) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Sodium, serum-high (hypernatremia) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Sodium, serum-low (hyponatremia) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Uric acid, serum-high (hyperuricemia) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Acute graft versus host disease (GVHD) (COH) Investigations MedDRA (9.0) Systematic Assessment EG000 2 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Graft versus host disease Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Veno-Occlusive Disease (VOD) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Muscle weakness, generalized or specific area (not due to neuropathy) Musculoskeletal and connective tissue disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Apnea Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Confusion Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Extrapyramidal/involuntary movement/restlessness Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Neuropathy: motor Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Somnolence/depressed level of consciousness Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Renal failure Renal and urinary disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Adult Respiratory Distress Syndrome (ARDS) Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Dyspnea (shortness of breath) Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Hypoxia Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Pleural effusion (non-malignant) Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Pneumonitis/pulmonary infiltrates Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Pulmonary/Upper Respiratory - Other (Specify, __) Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 1 affected 130 at risk EG003 Rash/desquamation associated with GVHD for BMT studies, if specified in the protocol. Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Rash: hand-foot skin reaction Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003
Term Organ System Source Vocabulary Assessment Type Notes Statistical Information Bone marrow cellularity Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 0 events 0 affected 4 at risk EG004 0 events 0 affected 40 at risk EG005 0 events 0 affected 2 at risk Coagulation - Other (Specify, __) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 DIC (disseminated intravascular coagulation) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Fibrinogen Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Hematemesis Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Hematuria (in the absence of vaginal bleeding) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Hemoglobin Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 4 events 4 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 8 events 8 affected 130 at risk EG003 Hemoglobin for leukemia studies or bone marrow infiltrative/myelophthisic processes Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Hemorrhage, pulmonary/upper respiratory Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Hemorrhage/Bleeding - Other (Specify, __) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 5 events 4 affected 130 at risk EG003 Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 6 events 6 affected 130 at risk EG003 Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 INR (International Normalized Ratio of prothrombin time) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Leukocytes (total WBC) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Leukocytes (total WBC) for BMT studies, if specified in the protocol. Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 10 events 10 affected 130 at risk EG003 Lymphopenia Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 10 events 10 affected 130 at risk EG003 Melena/GI bleeding Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Neutrophils/granulocytes (ANC/AGC) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol. Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 9 events 9 affected 130 at risk EG003 PTT (Partial Thromboplastin Time) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Platelets Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Platelets for BMT studies, if specified in the protocol. Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 10 events 10 affected 130 at risk EG003 Prothrombin Time Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Transfusion: Platelets for BMT studies, if specified in the protocol. Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 9 events 9 affected 130 at risk EG003 Transfusion: pRBCs Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Transfusion: pRBCs for BMT studies, if specified in the protocol. Blood and lymphatic system disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 7 events 7 affected 130 at risk EG003 Cardiac General - Other (Specify, __) Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Conduction abnormality/atrioventricular heart block Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Edema Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Hypertension Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 7 events 7 affected 130 at risk EG003 Hypotension Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 6 events 6 affected 130 at risk EG003 Left ventricular systolic dysfunction Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Supraventricular and nodal arrhythmia Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 3 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 8 events 6 affected 130 at risk EG003 Vasovagal episode Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Ventricular arrhythmia Cardiac disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Auditory/Ear - Other (Specify, __) Ear and labyrinth disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Hearing: patients without baseline audiogram and not enrolled in a monitoring program Ear and labyrinth disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Hot flashes/flushes Endocrine disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Dry eye syndrome Eye disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Ocular surface disease Eye disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Ocular/Visual - Other (Specify, __) Eye disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Ophthalmoplegia/diplopia (double vision) Eye disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Vision-blurred vision Eye disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Vision-photophobia Eye disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Anorexia Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 10 events 10 affected 130 at risk EG003 Colitis Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Constipation Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Dehydration Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Diarrhea Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 6 events 6 affected 130 at risk EG003 Diarrhea associated with GVHD for BMT studies, if specified in the protocol. Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 12 events 12 affected 130 at risk EG003 Dry mouth/salivary gland (xerostomia) Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Dysphagia (difficulty swallowing) Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Dysphagia-esophageal related to radiation Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Esophagitis Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Flatulence Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Gastrointestinal - Other (Specify, __) Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Heartburn/dyspepsia Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Mucositis due to radiation Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Mucositis/stomatitis (functional/symptomatic) Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Nausea Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 5 events 5 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 12 events 12 affected 130 at risk EG003 Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol. Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 6 events 6 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 15 events 15 affected 130 at risk EG003 Taste alteration (dysgeusia) Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Vomiting Gastrointestinal disorders MedDRA (9.0) Systematic Assessment EG000 4 events 4 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 10 events 10 affected 130 at risk EG003 Constitutional Symptoms - Other (Specify, __) General disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Fatigue (asthenia, lethargy, malaise) General disorders MedDRA (9.0) Systematic Assessment EG000 4 events 4 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 15 events 15 affected 130 at risk EG003 Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) General disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Insomnia General disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Pain General disorders MedDRA (9.0) Systematic Assessment EG000 9 events 5 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 19 events 11 affected 130 at risk EG003 Pain - Other (Specify, __) General disorders MedDRA (9.0) Systematic Assessment EG000 11 events 6 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 18 events 10 affected 130 at risk EG003 Rigors/chills General disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Sweating (diaphoresis) General disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Weight gain General disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 5 events 5 affected 130 at risk EG003 Weight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified in the protocol. General disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Weight loss General disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Bilirubin associated with GVHD for BMT studies, if specified in the protocol. Hepatobiliary disorders MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 9 events 9 affected 130 at risk EG003 Liver dysfunction/failure (clinical) Hepatobiliary disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Allergic reaction/hypersensitivity (including drug fever) Immune system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) Immune system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Febrile neutropenia (ANC <1.0 x 10e9/L, fever >=38.5 degrees C) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 6 events 6 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 9 events 9 affected 130 at risk EG003 Infection with grade 3 or 4 neutropenia (ANC <1.0 x 10e9/L) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 6 events 6 affected 130 at risk EG003 Infection - Other (Specify, __) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Infection with unknown ANC Infections and infestations MedDRA (9.0) Systematic Assessment EG000 4 events 4 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 8 events 8 affected 130 at risk EG003 Infection without neutropenia Infections and infestations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 6 events 6 affected 130 at risk EG003 Infection, Bacterial (COH) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 5 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 20 events 14 affected 130 at risk EG003 Infection, Fungal (COH) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Infection, Viral (COH) Infections and infestations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 5 events 4 affected 130 at risk EG003 ALT, SGPT (serum glutamic pyruvic transaminase) Investigations MedDRA (9.0) Systematic Assessment EG000 5 events 5 affected 62 at risk EG001 2 events 2 affected 17 at risk EG002 12 events 12 affected 130 at risk EG003 AST, SGOT(serum glutamic oxaloacetic transaminase) Investigations MedDRA (9.0) Systematic Assessment EG000 4 events 4 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 11 events 11 affected 130 at risk EG003 Acidosis (metabolic or respiratory) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Albumin, serum-low (hypoalbuminemia) Investigations MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 9 events 9 affected 130 at risk EG003 Alkaline phosphatase Investigations MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 8 events 8 affected 130 at risk EG003 Alkalosis (metabolic or respiratory) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Bicarbonate, serum-low Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Bilirubin (hyperbilirubinemia) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 5 events 5 affected 130 at risk EG003 Calcium, serum-high (hypercalcemia) Investigations MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Calcium, serum-low (hypocalcemia) Investigations MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 12 events 12 affected 130 at risk EG003 Cholesterol, serum-high (hypercholesteremia) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Creatinine Investigations MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 9 events 9 affected 130 at risk EG003 Glucose, serum-high (hyperglycemia) Investigations MedDRA (9.0) Systematic Assessment EG000 6 events 6 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 12 events 12 affected 130 at risk EG003 Glucose, serum-low (hypoglycemia) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Lipase Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Magnesium, serum-high (hypermagnesemia) Investigations MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Magnesium, serum-low (hypomagnesemia) Investigations MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 9 events 9 affected 130 at risk EG003 Metabolic/Laboratory - Other (Specify, __) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Phosphate, serum-low (hypophosphatemia) Investigations MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 6 events 6 affected 130 at risk EG003 Potassium, serum-high (hyperkalemia) Investigations MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 8 events 8 affected 130 at risk EG003 Potassium, serum-low (hypokalemia) Investigations MedDRA (9.0) Systematic Assessment EG000 4 events 4 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 10 events 10 affected 130 at risk EG003 Sodium, serum-high (hypernatremia) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Sodium, serum-low (hyponatremia) Investigations MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 11 events 11 affected 130 at risk EG003 Uric acid, serum-high (hyperuricemia) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Acute graft versus host disease (GVHD) (COH) Investigations MedDRA (9.0) Systematic Assessment EG000 5 events 4 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 26 events 19 affected 130 at risk EG003 Failure to engraft Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Graft versus host disease Investigations MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 18 events 17 affected 130 at risk EG003 Veno-Occlusive Disease (VOD) Investigations MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Arthritis (non-septic) Musculoskeletal and connective tissue disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Muscle weakness, generalized or specific area (not due to neuropathy) Musculoskeletal and connective tissue disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Musculoskeletal/Soft Tissue - Other (Specify, __) Musculoskeletal and connective tissue disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Apnea Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Ataxia (incoordination) Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Confusion Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 1 events 1 affected 17 at risk EG002 8 events 8 affected 130 at risk EG003 Dizziness Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Extrapyramidal/involuntary movement/restlessness Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Hallucinations Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 3 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Mood alteration Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 4 events 3 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 6 events 5 affected 130 at risk EG003 Neurology - Other (Specify, __) Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Neuropathy: motor Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Neuropathy: sensory Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Seizure Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Somnolence/depressed level of consciousness Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Speech impairment (e.g., dysphasia or aphasia) Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Syncope (fainting) Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Tremor Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Vertigo Nervous system disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Bladder spasms Renal and urinary disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Cystitis (COH) Renal and urinary disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Incontinence Renal and urinary disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Renal failure Renal and urinary disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 2 events 2 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Renal/Genitourinary - Other (Specify, __) Renal and urinary disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Urinary frequency/urgency Renal and urinary disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Urinary retention (including neurogenic bladder) Renal and urinary disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Gynecomastia Reproductive system and breast disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Sexual/Reproductive Function - Other (Specify, __) Reproductive system and breast disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Vaginitis (not due to infection) Reproductive system and breast disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Adult Respiratory Distress Syndrome (ARDS) Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 5 events 5 affected 130 at risk EG003 Cough Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 7 events 7 affected 130 at risk EG003 Dyspnea (shortness of breath) Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 11 events 11 affected 130 at risk EG003 Hiccoughs (hiccups, singultus) Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Hypoxia Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 8 events 8 affected 130 at risk EG003 Pleural effusion (non-malignant) Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 1 events 1 affected 130 at risk EG003 Pneumonitis/pulmonary infiltrates Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 7 events 7 affected 130 at risk EG003 Pulmonary/Upper Respiratory - Other (Specify, __) Respiratory, thoracic and mediastinal disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 12 events 4 affected 130 at risk EG003 Dermatology/Skin - Other (Specify, __) Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 7 events 4 affected 130 at risk EG003 Dry skin Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Flushing Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Hair loss/alopecia (scalp or body) Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 3 events 3 affected 130 at risk EG003 Injection site reaction/extravasation changes Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003 Pigmentation changes (e.g., vitiligo) Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 0 events 0 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Pruritus/itching Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 2 events 2 affected 130 at risk EG003 Rash/dermatitis associated with high-dose chemotherapy or BMT studies. Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 2 events 2 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Rash/desquamation Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 4 events 4 affected 130 at risk EG003 Rash/desquamation associated with GVHD for BMT studies, if specified in the protocol. Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 4 events 4 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 5 events 5 affected 130 at risk EG003 Urticaria (hives, welts, wheals) Skin and subcutaneous tissue disorders MedDRA (9.0) Systematic Assessment EG000 1 events 1 affected 62 at risk EG001 0 events 0 affected 17 at risk EG002 0 events 0 affected 130 at risk EG003
Are all PI(s) employees of the sponsor? Yes
Results Disclosure Restriction on PI(s)? Not provided
Title Organization Phone Extension Email Dr. Monzr Al Malki, MD City of Hope 626359811 malmalki@coh.org
ID Term D009196 Myeloproliferative Disorders D006086 Graft vs Host Disease D007938 Leukemia D008223 Lymphoma D009101 Multiple Myeloma D054219 Neoplasms, Plasma Cell D009190 Myelodysplastic Syndromes D054437 Myelodysplastic-Myeloproliferative Diseases D011230 Precancerous Conditions D054198 Precursor Cell Lymphoblastic Leukemia-Lymphoma D000754 Anemia, Refractory, with Excess of Blasts D054438 Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative D015477 Leukemia, Myelomonocytic, Chronic D054429 Leukemia, Myelomonocytic, Juvenile D015470 Leukemia, Myeloid, Acute D000013 Congenital Abnormalities D015465 Leukemia, Myeloid, Accelerated Phase D001752 Blast Crisis D015466 Leukemia, Myeloid, Chronic-Phase C580364 Pdgfra-Associated Chronic Eosinophilic Leukemia D055728 Primary Myelofibrosis D015467 Leukemia, Neutrophilic, Chronic D013920 Thrombocythemia, Essential D011087 Polycythemia Vera D008258 Waldenstrom Macroglobulinemia D018442 Lymphoma, B-Cell, Marginal Zone D002051 Burkitt Lymphoma D016403 Lymphoma, Large B-Cell, Diffuse D008228 Lymphoma, Non-Hodgkin D016400 Lymphoma, Large-Cell, Immunoblastic D008224 Lymphoma, Follicular D020522 Lymphoma, Mantle-Cell D015451 Leukemia, Lymphocytic, Chronic, B-Cell D054391 Lymphoma, Extranodal NK-T-Cell D054739 Dendritic Cell Sarcoma, Interdigitating D017728 Lymphoma, Large-Cell, Anaplastic D007119 Immunoblastic Lymphadenopathy D054218 Precursor T-Cell Lymphoblastic Leukemia-Lymphoma D006689 Hodgkin Disease D012008 Recurrence D000741 Anemia, Aplastic D006457 Hemoglobinuria, Paroxysmal D016410 Lymphoma, T-Cell, Cutaneous D009182 Mycosis Fungoides D012751 Sezary Syndrome
ID Term D001855 Bone Marrow Diseases D006402 Hematologic Diseases D006425 Hemic and Lymphatic Diseases D007154 Immune System Diseases D009370 Neoplasms by Histologic Type D009369 Neoplasms D008232 Lymphoproliferative Disorders D008206 Lymphatic Diseases D007160 Immunoproliferative Disorders D020141 Hemostatic Disorders D014652 Vascular Diseases D002318 Cardiovascular Diseases D010265 Paraproteinemias D001796 Blood Protein Disorders D006474 Hemorrhagic Disorders D007945 Leukemia, Lymphoid D000753 Anemia, Refractory D000740 Anemia D007951 Leukemia, Myeloid D002908 Chronic Disease D020969 Disease Attributes D010335 Pathologic Processes D013568 Pathological Conditions, Signs and Symptoms D009358 Congenital, Hereditary, and Neonatal Diseases and Abnormalities D015464 Leukemia, Myelogenous, Chronic, BCR-ABL Positive D002471 Cell Transformation, Neoplastic D063646 Carcinogenesis D009385 Neoplastic Processes D001778 Blood Coagulation Disorders D013922 Thrombocytosis D001791 Blood Platelet Disorders D019046 Bone Marrow Neoplasms D019337 Hematologic Neoplasms D009371 Neoplasms by Site D016393 Lymphoma, B-Cell D020031 Epstein-Barr Virus Infections D006566 Herpesviridae Infections D004266 DNA Virus Infections D014777 Virus Diseases D007239 Infections D014412 Tumor Virus Infections D015448 Leukemia, B-Cell D016399 Lymphoma, T-Cell D015620 Histiocytic Disorders, Malignant D015614 Histiocytosis D000072281 Lymphadenopathy D000080983 Bone Marrow Failure Disorders D000743 Anemia, Hemolytic
ID Term D002066 Busulfan D003520 Cyclophosphamide D016572 Cyclosporine D005047 Etoposide C042382 fludarabine phosphate D008558 Melphalan D008727 Methotrexate D009173 Mycophenolic Acid D020123 Sirolimus D016559 Tacrolimus D036102 Peripheral Blood Stem Cell Transplantation D014916 Whole-Body Irradiation
ID Term D002072 Butylene Glycols D006018 Glycols D000438 Alcohols D009930 Organic Chemicals D008698 Mesylates D000476 Alkanesulfonates D017738 Alkanesulfonic Acids D000473 Alkanes D006839 Hydrocarbons, Acyclic D006838 Hydrocarbons D013451 Sulfonic Acids D013456 Sulfur Acids D013457 Sulfur Compounds D010752 Phosphoramide Mustards D009588 Nitrogen Mustard Compounds D009150 Mustard Compounds D006846 Hydrocarbons, Halogenated D063088 Phosphoramides D009943 Organophosphorus Compounds D003524 Cyclosporins D010456 Peptides, Cyclic D047028 Macrocyclic Compounds D011083 Polycyclic Compounds D010455 Peptides D000602 Amino Acids, Peptides, and Proteins D011034 Podophyllotoxin D013764 Tetrahydronaphthalenes D009281 Naphthalenes D011084 Polycyclic Aromatic Hydrocarbons D006841 Hydrocarbons, Aromatic D006844 Hydrocarbons, Cyclic D005960 Glucosides D006027 Glycosides D002241 Carbohydrates D010649 Phenylalanine D024322 Amino Acids, Aromatic D000598 Amino Acids, Cyclic D000596 Amino Acids D000630 Aminopterin D011622 Pterins D011621 Pteridines D006574 Heterocyclic Compounds, 2-Ring D000072471 Heterocyclic Compounds, Fused-Ring D006571 Heterocyclic Compounds D002208 Caproates D000144 Acids, Acyclic D002264 Carboxylic Acids D005227 Fatty Acids D008055 Lipids D018942 Macrolides D007783 Lactones D018380 Hematopoietic Stem Cell Transplantation D033581 Stem Cell Transplantation D017690 Cell Transplantation D064987 Cell- and Tissue-Based Therapy D001691 Biological Therapy D013812 Therapeutics D014180 Transplantation D013514 Surgical Procedures, Operative D011878 Radiotherapy D008919 Investigative Techniques
22
(18 to 42)
BG004 37 (7 to 58)
BG005 44 (41 to 47)
BG006 44 (6 to 67) 65
BG003 2
BG004 17
BG005 1
BG006 120 Male BG000 38 BG001 6 BG002 65 BG003 2 BG004 23 BG005 1 BG006 135
0
BG003 0
BG004 0
BG005 0
BG006 1 Asian BG000 2 BG001 0 BG002 8 BG003 1 BG004 2 BG005 0 BG006 13
Native Hawaiian or Other Pacific Islander BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0
Black or African American BG000 0 BG001 0 BG002 3 BG003 1 BG004 0 BG005 0 BG006 4
White BG000 55 BG001 17 BG002 118 BG003 2 BG004 38 BG005 2 BG006 232
More than one race BG000 0 BG001 0 BG002 0 BG003 0 BG004 0 BG005 0 BG006 0
Unknown or Not Reported BG000 4 BG001 0 BG002 1 BG003 0 BG004 0 BG005 0 BG006 5
130
BG003 4
BG004 40
BG005 2
BG006 255 3
OG004 36
OG005 1 14
(14 to 17)
OG004 18 (11 to 28)
OG005 16 (16 to 16) OG002 Regimen III Patients undergo TBI on days -7 to -4 and receive etoposide IV on day -3.
cyclosporine
etoposide
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
OG003 Regimen IV Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and melphalan IV on day -2.
cyclosporine
fludarabine phosphate
melphalan
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
OG004 Regimen V Patients receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo TBI on day 0.
cyclosporine
fludarabine phosphate
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
total-body irradiation
OG005 Regimen VI Patients receive busulfan IV over 3 hours and fludarabine phosphate IV over 30 minutes on days -5 to -2.
busulfan
cyclosporine
fludarabine phosphate
methotrexate
mycophenolate mofetil
sirolimus
tacrolimus
allogeneic hematopoietic stem cell transplantation
peripheral blood stem cell transplantation
Units Counts Participants OG000 62 OG001 16 OG002 130 OG003 4 OG004 40 OG005 2
Title Denominators Categories Title Measurements OG000 58 (45 to 69) OG001 50 (25 to 71) OG002 54 (45 to 62) OG003 50 (6 to 84) OG004 38 (23 to 52) OG005 50 (0.1 to 91)
1 events
1 affected
40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 1 events 1 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 1 events 1 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 1 events 1 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 1 events 1 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 1 events 1 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 1 events 1 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 1 events 1 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 1 events 1 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 0 events 0 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
4 at risk
EG004 1 events 1 affected 40 at risk
EG005 0 events 0 affected 2 at risk 0 events
0 affected
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