Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia
Study Details
Study Description
Brief Summary
This phase II clinical trial is studying how well giving busulfan, fludarabine phosphate, and anti-thymocyte globulin followed by donor stem cell transplant and azacitidine works in treating patients with high-risk myelodysplastic syndrome and older patients with acute myeloid leukemia. Giving low doses of chemotherapy, such as busulfan and fludarabine phosphate, before a donor stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-vs-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving anti-thymocyte globulin before transplant and giving azacitidine, tacrolimus, and methotrexate after the transplant may stop this from happening.
Detailed Description
PRIMARY OBJECTIVE:
- To determine if this treatment can improve 2-year progression-free survival (PFS) in patients with high risk myelodysplastic syndrome (MDS) and in patients with acute myeloid leukemia (AML) >= 60 yrs age
SECONDARY OBJECTIVES:
-
To determine the safety and feasibility of using post-transplantation azacitidine.
-
To determine the ability to use pharmacokinetic-directed busulfan to achieve area under the curve (AUC) within 20% of target AUC in > 80% of patients.
-
To determine the rate of grade II-IV and III-IV acute graft-vs-host disease (GVHD).
-
To determine the incidence of extensive chronic GVHD. V. To determine treatment-related mortality at 100 days and at 1 year. VI. To determine 5-year overall survival.
OUTLINE:
REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]).
TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1.
GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus orally (PO) or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD).
CONSOLIDATION: Beginning on day 42, patients receive azacitidine subcutaneously (SC) or IV on days 1-5.
Treatment repeats every 4 weeks for 6 courses. Blood and bone marrow samples may be collected periodically for correlative and pharmacokinetic studies.
After completion of study treatment, patients are followed up every 6 months for 5 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment (chemotherapy and transplant) REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1. |
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo allogeneic hematopoietic stem cell transplantation
Other Names:
Biological: Anti-Thymocyte Globulin
Given IV
Other Names:
Drug: Azacitidine
Given SC or IV
Other Names:
Drug: Busulfan
Given IV
Other Names:
Drug: Fludarabine Phosphate
Given IV
Other Names:
Other: Laboratory Biomarker Analysis
Correlative studies
Drug: Methotrexate
Given IV
Other Names:
Other: Pharmacological Study
Correlative studies
Drug: Tacrolimus
Given PO or IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Progression-free Survival [Up to 5 years]
Progression-free survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are alive and progression free at 2 and 5 years from date of transplantation respectively. AML progression is defined as: Reappearance of leukemia blast cells in peripheral blood and > 5% blasts in marrow If no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow >= 1 week later with > 5% blasts Development of extramedullary leukemia MDS progression is defined as For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts Any of the following: Reappearance of prior documented characteristic cytogenetic abnormality or refractory cytopenias with unequivocal evidence of dysplasia on bone marrow biopsy/aspirate
Secondary Outcome Measures
- Overall Survival (OS) [Up to 5 years]
Overall survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are still alive 2 and 5 years after date of transplantation respectively. Estimated using the Kaplan-Meier product limit estimator.
- 100-day Mortality [Up to 100 days post-treatment]
The number of death reported within the first 100 days after transplant.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Meets one of the following sets of criteria:
-
Myelodysplastic syndromes (MDS):
-
Disease with high-risk features (found either at diagnosis or before initiation of cytotoxic therapy), defined as one of the following:
-
International prognostic scoring system (IPSS) risk >= intermediate-2
-
Refractory anemia with excess blasts by French-American-British (FAB) classification
-
High-risk cytogenetics (either complex or -7)
-
Less than 10% bone marrow blasts as determined by bone marrow biopsy within the past 4 weeks (reduction in marrow blast percentage may be achieved with chemotherapy or other therapy)
-
Less than 75 years old
-
Acute myeloid leukemia (AML):
-
No FAB M3
-
No acute leukemia following blast transformation of prior chronic myelogenous leukemia or other myeloproliferative disease
-
Patients with preceding MDS or treatment-related AML are eligible
-
Prior central nervous system (CNS) involvement is allowed provided the disease is in remission at transplantation
-
Morphologic complete remission (leukemia-free state) is defined as meeting all of the following criteria:
-
Bone marrow blasts < 5% (as determined by bone marrow within the past 4 weeks), but without requirement for normal peripheral blood counts
-
No extramedullary leukemia
-
No blasts in peripheral blood
-
Achieved complete remission (CR) after no more than 2 courses of induction chemotherapy
-
Patients treated with azacitidine or decitabine who achieve a leukemia-free state are eligible (may have required up to 4 courses of therapy to reach this status)
-
Age 60 to 74 years
-
Donors must meet the following criteria:
-
One of the following:
-
HLA-identical sibling (6/6) by serologic typing for class (A, B) and low-resolution molecular typing for class II (DRB1)
-
Matched unrelated donor (8/8) by high-resolution molecular typing at HLA-A, -B, -C, and DRB1
-
No syngeneic donors
-
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
-
Calculated creatinine clearance ≥ 40 mL/min
-
Bilirubin < 2 mg/dL OR bilirubin 2-3 mg/dL provided direct bilirubin is normal
-
Aspartate aminotransferase (AST) < 3 times upper limit of normal
-
Diffusing capacity of the lung for carbon monoxide (DLCO) > 40% with no symptomatic pulmonary disease
-
Left ventricle ejection fraction (LVEF) >= 30% by echocardiogram (ECHO) or multigated acquisition (MUGA)
-
Not pregnant or nursing
-
Negative pregnancy test
-
Fertile patients must use effective contraception
-
No uncontrolled diabetes mellitus or active serious infections
-
No known hypersensitivity to E. coli-derived products, azacitidine, or mannitol
-
No human immunodeficiency virus (HIV) infection or active hepatitis B or C
-
Prior azacitidine or decitabine allowed
-
No patients who progressed from MDS to AML during treatment with azacitidine or decitabine
-
At least 4 weeks since prior deoxyribonucleic acid (DNA)-hypomethylating chemotherapy, radiotherapy, and/or surgery
-
No more than 2 courses of consolidation therapy before transplantation (for patients with AML)
-
Any consolidation regimen that does not require transplantation can be used
-
No more than 6 months from documentation of morphologic CR to transplantation
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Beebe Medical Center | Lewes | Delaware | United States | 19958 |
2 | Christiana Care Health System-Christiana Hospital | Newark | Delaware | United States | 19718 |
3 | AdventHealth Orlando | Orlando | Florida | United States | 32803 |
4 | University of Iowa/Holden Comprehensive Cancer Center | Iowa City | Iowa | United States | 52242 |
5 | University of Maryland/Greenebaum Cancer Center | Baltimore | Maryland | United States | 21201 |
6 | Christiana Care - Union Hospital | Elkton | Maryland | United States | 21921 |
7 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
8 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
9 | Cooper Hospital University Medical Center | Camden | New Jersey | United States | 08103 |
10 | Northwell Health NCORP | Lake Success | New York | United States | 11042 |
11 | Northwell Health/Center for Advanced Medicine | Lake Success | New York | United States | 11042 |
12 | North Shore University Hospital | Manhasset | New York | United States | 11030 |
13 | Mount Sinai Hospital | New York | New York | United States | 10029 |
14 | NYP/Weill Cornell Medical Center | New York | New York | United States | 10065 |
15 | UNC Lineberger Comprehensive Cancer Center | Chapel Hill | North Carolina | United States | 27599 |
16 | Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States | 27157 |
17 | Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210 |
Sponsors and Collaborators
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Ravi Vij, Alliance for Clinical Trials in Oncology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCI-2011-02053
- NCI-2011-02053
- CDR0000681025
- CALGB-100801
- CALGB 100801
- CALGB-100801
- U10CA180821
- U10CA031946
Study Results
Participant Flow
Recruitment Details | From July 2010 and October 2013, a total of 68 participants were recruited to this study. |
---|---|
Pre-assignment Detail |
Arm/Group Title | Treatment (Chemotherapy and Transplant) |
---|---|
Arm/Group Description | REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1. |
Period Title: Overall Study | |
STARTED | 68 |
COMPLETED | 63 |
NOT COMPLETED | 5 |
Baseline Characteristics
Arm/Group Title | Treatment (Chemotherapy and Transplant) |
---|---|
Arm/Group Description | REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1. |
Overall Participants | 68 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
62.9
|
Sex: Female, Male (Count of Participants) | |
Female |
15
22.1%
|
Male |
53
77.9%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
3
4.4%
|
Not Hispanic or Latino |
61
89.7%
|
Unknown or Not Reported |
4
5.9%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
1
1.5%
|
Asian |
2
2.9%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
1
1.5%
|
White |
60
88.2%
|
More than one race |
2
2.9%
|
Unknown or Not Reported |
2
2.9%
|
Region of Enrollment (Count of Participants) | |
United States |
68
100%
|
Disease type (Count of Participants) | |
Myelodysplastic Syndrome (MDS) |
24
35.3%
|
Acute Myeloid Leukemia (AML) |
44
64.7%
|
Outcome Measures
Title | Progression-free Survival |
---|---|
Description | Progression-free survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are alive and progression free at 2 and 5 years from date of transplantation respectively. AML progression is defined as: Reappearance of leukemia blast cells in peripheral blood and > 5% blasts in marrow If no circulating blasts, but the marrow contains 5-20% blasts, a repeat bone marrow >= 1 week later with > 5% blasts Development of extramedullary leukemia MDS progression is defined as For patients with <5% bone marrow blasts: ≥50% increase in blasts to >5% blasts For patients with 5-10% bone marrow blasts: ≥50% increase to >10% blasts Any of the following: Reappearance of prior documented characteristic cytogenetic abnormality or refractory cytopenias with unequivocal evidence of dysplasia on bone marrow biopsy/aspirate |
Time Frame | Up to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Patients who received transplant were evaluable for the primary endpoint. |
Arm/Group Title | Treatment (Chemotherapy and Transplant) |
---|---|
Arm/Group Description | REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1. |
Measure Participants | 63 |
PFS at 2 years |
41.2
|
PFS at 5 years |
26.9
|
Title | Overall Survival (OS) |
---|---|
Description | Overall survival rate (percentage) at 2 and 5 years is defined as the percentage of patients who are still alive 2 and 5 years after date of transplantation respectively. Estimated using the Kaplan-Meier product limit estimator. |
Time Frame | Up to 5 years |
Outcome Measure Data
Analysis Population Description |
---|
Patients who received transplant were evaluable for this endpoint. |
Arm/Group Title | Treatment (Chemotherapy and Transplant) |
---|---|
Arm/Group Description | REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1. |
Measure Participants | 63 |
OS at 2 years |
45.7
|
OS at 5 years |
31.2
|
Title | 100-day Mortality |
---|---|
Description | The number of death reported within the first 100 days after transplant. |
Time Frame | Up to 100 days post-treatment |
Outcome Measure Data
Analysis Population Description |
---|
Patients who received transplant and died are included in this analysis. |
Arm/Group Title | Treatment (Chemotherapy and Transplant) |
---|---|
Arm/Group Description | REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1. |
Measure Participants | 63 |
Count of Participants [Participants] |
10
14.7%
|
Adverse Events
Time Frame | ||
---|---|---|
Adverse Event Reporting Description | 2 patients who cancelled prior to receiving any study treatment are excluded from this analysis | |
Arm/Group Title | Treatment (Chemotherapy and Transplant) | |
Arm/Group Description | REDUCED-INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3, busulfan IV over 45 minutes on days -6 to -3, and anti-thymocyte globulin IV over 4-10 hours on days -6 to -5 (matched sibling donor [MSD]) or -6 to -4 (matched unrelated donor [MUD]). TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0 or on days 0-1. GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus PO or IV on days -2 to 90 with taper on days 150-180. Patients also receive methotrexate IV on days 1, 3, 6 (MSD), and 11 (MUD). CONSOLIDATION: Beginning on day 42, patients receive azacitidine SC or IV on days 1. | |
All Cause Mortality |
||
Treatment (Chemotherapy and Transplant) | ||
Affected / at Risk (%) | # Events | |
Total | 42/66 (63.6%) | |
Serious Adverse Events |
||
Treatment (Chemotherapy and Transplant) | ||
Affected / at Risk (%) | # Events | |
Total | 22/66 (33.3%) | |
Blood and lymphatic system disorders | ||
Anemia | 18/66 (27.3%) | 19 |
Blood and lymphatic system disorders - Other, specify | 1/66 (1.5%) | 1 |
Disseminated intravascular coagulation | 1/66 (1.5%) | 1 |
Febrile neutropenia | 3/66 (4.5%) | 3 |
Cardiac disorders | ||
Atrial fibrillation | 3/66 (4.5%) | 3 |
Cardiac arrest | 2/66 (3%) | 2 |
Conduction disorder | 1/66 (1.5%) | 1 |
Heart failure | 2/66 (3%) | 2 |
Left ventricular systolic dysfunction | 1/66 (1.5%) | 1 |
Sinus bradycardia | 4/66 (6.1%) | 4 |
Sinus tachycardia | 7/66 (10.6%) | 7 |
Supraventricular tachycardia | 1/66 (1.5%) | 1 |
Ear and labyrinth disorders | ||
Ear and labyrinth disorders - Other, specify | 1/66 (1.5%) | 1 |
Ear pain | 3/66 (4.5%) | 3 |
Hearing impaired | 1/66 (1.5%) | 1 |
Endocrine disorders | ||
Cushingoid | 1/66 (1.5%) | 1 |
Growth accelerated | 1/66 (1.5%) | 1 |
Eye disorders | ||
Blurred vision | 1/66 (1.5%) | 1 |
Cataract | 1/66 (1.5%) | 1 |
Dry eye | 1/66 (1.5%) | 1 |
Eye disorders - Other, specify | 4/66 (6.1%) | 4 |
Scleral disorder | 1/66 (1.5%) | 1 |
Vitreous hemorrhage | 1/66 (1.5%) | 1 |
Gastrointestinal disorders | ||
Abdominal distension | 2/66 (3%) | 2 |
Abdominal pain | 7/66 (10.6%) | 7 |
Ascites | 1/66 (1.5%) | 1 |
Constipation | 5/66 (7.6%) | 5 |
Diarrhea | 12/66 (18.2%) | 13 |
Dry mouth | 4/66 (6.1%) | 4 |
Dyspepsia | 2/66 (3%) | 2 |
Enterocolitis | 1/66 (1.5%) | 1 |
Esophagitis | 1/66 (1.5%) | 1 |
Fecal incontinence | 3/66 (4.5%) | 3 |
Gastrointestinal disorders - Other, specify | 6/66 (9.1%) | 7 |
Hemorrhoids | 3/66 (4.5%) | 3 |
Intra-abdominal hemorrhage | 1/66 (1.5%) | 1 |
Lower gastrointestinal hemorrhage | 1/66 (1.5%) | 1 |
Mucositis oral | 4/66 (6.1%) | 4 |
Nausea | 11/66 (16.7%) | 13 |
Oral hemorrhage | 1/66 (1.5%) | 1 |
Oral pain | 1/66 (1.5%) | 1 |
Rectal hemorrhage | 1/66 (1.5%) | 1 |
Rectal pain | 1/66 (1.5%) | 1 |
Vomiting | 8/66 (12.1%) | 9 |
General disorders | ||
Chills | 4/66 (6.1%) | 4 |
Death NOS | 1/66 (1.5%) | 1 |
Edema face | 2/66 (3%) | 2 |
Edema limbs | 10/66 (15.2%) | 12 |
Edema trunk | 3/66 (4.5%) | 3 |
Fatigue | 12/66 (18.2%) | 13 |
Fever | 2/66 (3%) | 2 |
General disorders and administration site conditions - Other, specify | 2/66 (3%) | 2 |
Hypothermia | 1/66 (1.5%) | 1 |
Localized edema | 1/66 (1.5%) | 1 |
Malaise | 2/66 (3%) | 2 |
Non-cardiac chest pain | 1/66 (1.5%) | 2 |
Pain | 3/66 (4.5%) | 3 |
Hepatobiliary disorders | ||
Cholecystitis | 1/66 (1.5%) | 1 |
Hepatic failure | 2/66 (3%) | 2 |
Hepatic hemorrhage | 1/66 (1.5%) | 1 |
Portal vein thrombosis | 1/66 (1.5%) | 1 |
Infections and infestations | ||
Catheter related infection | 1/66 (1.5%) | 1 |
Enterocolitis infectious | 1/66 (1.5%) | 1 |
Infections and infestations - Other, specify | 6/66 (9.1%) | 6 |
Lung infection | 6/66 (9.1%) | 7 |
Mucosal infection | 2/66 (3%) | 2 |
Sepsis | 4/66 (6.1%) | 4 |
Sinusitis | 1/66 (1.5%) | 1 |
Upper respiratory infection | 1/66 (1.5%) | 1 |
Urinary tract infection | 1/66 (1.5%) | 1 |
Injury, poisoning and procedural complications | ||
Bruising | 4/66 (6.1%) | 4 |
Fall | 2/66 (3%) | 2 |
Investigations | ||
Activated partial thromboplastin time prolonged | 5/66 (7.6%) | 5 |
Alanine aminotransferase increased | 11/66 (16.7%) | 11 |
Alkaline phosphatase increased | 10/66 (15.2%) | 10 |
Aspartate aminotransferase increased | 11/66 (16.7%) | 11 |
Blood bilirubin increased | 7/66 (10.6%) | 7 |
Cholesterol high | 1/66 (1.5%) | 1 |
Creatinine increased | 10/66 (15.2%) | 11 |
Ejection fraction decreased | 1/66 (1.5%) | 1 |
Electrocardiogram QT corrected interval prolonged | 1/66 (1.5%) | 1 |
Fibrinogen decreased | 2/66 (3%) | 2 |
INR increased | 3/66 (4.5%) | 3 |
Investigations - Other, specify | 3/66 (4.5%) | 9 |
Lymphocyte count decreased | 5/66 (7.6%) | 5 |
Neutrophil count decreased | 10/66 (15.2%) | 11 |
Platelet count decreased | 16/66 (24.2%) | 17 |
Weight gain | 1/66 (1.5%) | 1 |
Weight loss | 5/66 (7.6%) | 7 |
White blood cell decreased | 8/66 (12.1%) | 8 |
Metabolism and nutrition disorders | ||
Acidosis | 3/66 (4.5%) | 4 |
Alkalosis | 2/66 (3%) | 2 |
Anorexia | 9/66 (13.6%) | 9 |
Dehydration | 1/66 (1.5%) | 1 |
Hypercalcemia | 1/66 (1.5%) | 1 |
Hyperglycemia | 14/66 (21.2%) | 15 |
Hyperkalemia | 5/66 (7.6%) | 5 |
Hypermagnesemia | 1/66 (1.5%) | 1 |
Hypernatremia | 3/66 (4.5%) | 3 |
Hypertriglyceridemia | 1/66 (1.5%) | 1 |
Hyperuricemia | 1/66 (1.5%) | 1 |
Hypoalbuminemia | 10/66 (15.2%) | 11 |
Hypocalcemia | 7/66 (10.6%) | 8 |
Hypoglycemia | 3/66 (4.5%) | 3 |
Hypokalemia | 4/66 (6.1%) | 4 |
Hypomagnesemia | 11/66 (16.7%) | 12 |
Hyponatremia | 9/66 (13.6%) | 10 |
Hypophosphatemia | 5/66 (7.6%) | 5 |
Metabolism and nutrition disorders - Other, specify | 6/66 (9.1%) | 8 |
Musculoskeletal and connective tissue disorders | ||
Arthralgia | 4/66 (6.1%) | 4 |
Back pain | 3/66 (4.5%) | 3 |
Generalized muscle weakness | 5/66 (7.6%) | 6 |
Musculoskeletal and connective tissue disorder - Other, specify | 1/66 (1.5%) | 1 |
Myalgia | 2/66 (3%) | 2 |
Pain in extremity | 3/66 (4.5%) | 4 |
Soft tissue necrosis lower limb | 1/66 (1.5%) | 1 |
Soft tissue necrosis upper limb | 1/66 (1.5%) | 1 |
Nervous system disorders | ||
Akathisia | 1/66 (1.5%) | 1 |
Depressed level of consciousness | 2/66 (3%) | 2 |
Dizziness | 2/66 (3%) | 2 |
Dysgeusia | 6/66 (9.1%) | 6 |
Encephalopathy | 1/66 (1.5%) | 1 |
Extrapyramidal disorder | 1/66 (1.5%) | 1 |
Headache | 2/66 (3%) | 2 |
Hypersomnia | 1/66 (1.5%) | 1 |
Lethargy | 1/66 (1.5%) | 1 |
Neuralgia | 1/66 (1.5%) | 1 |
Paresthesia | 1/66 (1.5%) | 1 |
Peripheral sensory neuropathy | 3/66 (4.5%) | 3 |
Presyncope | 1/66 (1.5%) | 1 |
Sinus pain | 1/66 (1.5%) | 1 |
Somnolence | 1/66 (1.5%) | 1 |
Syncope | 1/66 (1.5%) | 1 |
Tremor | 1/66 (1.5%) | 1 |
Psychiatric disorders | ||
Anxiety | 4/66 (6.1%) | 4 |
Confusion | 2/66 (3%) | 2 |
Delirium | 1/66 (1.5%) | 1 |
Depression | 3/66 (4.5%) | 3 |
Hallucinations | 1/66 (1.5%) | 1 |
Insomnia | 4/66 (6.1%) | 4 |
Psychiatric disorders - Other, specify | 1/66 (1.5%) | 1 |
Renal and urinary disorders | ||
Acute kidney injury | 4/66 (6.1%) | 4 |
Chronic kidney disease | 2/66 (3%) | 2 |
Hematuria | 1/66 (1.5%) | 1 |
Renal and urinary disorders - Other, specify | 2/66 (3%) | 2 |
Urinary frequency | 1/66 (1.5%) | 1 |
Urinary incontinence | 1/66 (1.5%) | 1 |
Urinary retention | 1/66 (1.5%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||
Atelectasis | 3/66 (4.5%) | 3 |
Cough | 6/66 (9.1%) | 6 |
Dyspnea | 8/66 (12.1%) | 8 |
Epistaxis | 3/66 (4.5%) | 3 |
Hypoxia | 7/66 (10.6%) | 8 |
Nasal congestion | 3/66 (4.5%) | 3 |
Pleural effusion | 2/66 (3%) | 2 |
Pleural hemorrhage | 1/66 (1.5%) | 1 |
Pneumonitis | 3/66 (4.5%) | 3 |
Pneumothorax | 3/66 (4.5%) | 3 |
Postnasal drip | 1/66 (1.5%) | 1 |
Productive cough | 2/66 (3%) | 2 |
Pulmonary fibrosis | 1/66 (1.5%) | 1 |
Pulmonary hypertension | 1/66 (1.5%) | 1 |
Respiratory failure | 5/66 (7.6%) | 5 |
Respiratory, thoracic and mediastinal disorders - Other, specify | 3/66 (4.5%) | 5 |
Skin and subcutaneous tissue disorders | ||
Dry skin | 4/66 (6.1%) | 4 |
Nail loss | 1/66 (1.5%) | 1 |
Pain of skin | 3/66 (4.5%) | 3 |
Rash maculo-papular | 5/66 (7.6%) | 6 |
Skin and subcutaneous tissue disorders - Other, specify | 3/66 (4.5%) | 9 |
Skin hypopigmentation | 1/66 (1.5%) | 1 |
Skin ulceration | 1/66 (1.5%) | 1 |
Surgical and medical procedures | ||
Surgical and medical procedures - Other, specify | 1/66 (1.5%) | 1 |
Vascular disorders | ||
Flushing | 1/66 (1.5%) | 1 |
Hot flashes | 1/66 (1.5%) | 1 |
Hypertension | 9/66 (13.6%) | 9 |
Hypotension | 10/66 (15.2%) | 12 |
Thromboembolic event | 3/66 (4.5%) | 3 |
Other (Not Including Serious) Adverse Events |
||
Treatment (Chemotherapy and Transplant) | ||
Affected / at Risk (%) | # Events | |
Total | 61/66 (92.4%) | |
Blood and lymphatic system disorders | ||
Anemia | 58/66 (87.9%) | 219 |
Blood and lymphatic system disorders - Other, specify | 2/66 (3%) | 3 |
Febrile neutropenia | 21/66 (31.8%) | 24 |
Hemolysis | 1/66 (1.5%) | 5 |
Leukocytosis | 4/66 (6.1%) | 5 |
Thrombotic thrombocytopenic purpura | 1/66 (1.5%) | 2 |
Cardiac disorders | ||
Atrial fibrillation | 8/66 (12.1%) | 21 |
Atrial flutter | 1/66 (1.5%) | 1 |
Cardiac disorders - Other, specify | 1/66 (1.5%) | 1 |
Chest pain - cardiac | 2/66 (3%) | 2 |
Heart failure | 1/66 (1.5%) | 1 |
Left ventricular systolic dysfunction | 1/66 (1.5%) | 1 |
Myocarditis | 1/66 (1.5%) | 1 |
Palpitations | 1/66 (1.5%) | 1 |
Paroxysmal atrial tachycardia | 1/66 (1.5%) | 1 |
Pericardial effusion | 1/66 (1.5%) | 1 |
Restrictive cardiomyopathy | 1/66 (1.5%) | 1 |
Sinus bradycardia | 15/66 (22.7%) | 20 |
Sinus tachycardia | 17/66 (25.8%) | 28 |
Supraventricular tachycardia | 1/66 (1.5%) | 1 |
Ventricular arrhythmia | 1/66 (1.5%) | 1 |
Ventricular tachycardia | 1/66 (1.5%) | 1 |
Ear and labyrinth disorders | ||
Ear and labyrinth disorders - Other, specify | 1/66 (1.5%) | 2 |
Ear pain | 3/66 (4.5%) | 3 |
Hearing impaired | 3/66 (4.5%) | 13 |
Vertigo | 1/66 (1.5%) | 1 |
Endocrine disorders | ||
Adrenal insufficiency | 1/66 (1.5%) | 2 |
Endocrine disorders - Other, specify | 3/66 (4.5%) | 3 |
Hypothyroidism | 1/66 (1.5%) | 7 |
Eye disorders | ||
Blurred vision | 18/66 (27.3%) | 45 |
Cataract | 2/66 (3%) | 4 |
Conjunctivitis | 2/66 (3%) | 2 |
Dry eye | 10/66 (15.2%) | 21 |
Eye disorders - Other, specify | 8/66 (12.1%) | 8 |
Eye pain | 4/66 (6.1%) | 5 |
Glaucoma | 2/66 (3%) | 9 |
Photophobia | 2/66 (3%) | 2 |
Scleral disorder | 1/66 (1.5%) | 1 |
Uveitis | 1/66 (1.5%) | 4 |
Vitreous hemorrhage | 1/66 (1.5%) | 1 |
Watering eyes | 5/66 (7.6%) | 6 |
Gastrointestinal disorders | ||
Abdominal distension | 5/66 (7.6%) | 8 |
Abdominal pain | 23/66 (34.8%) | 36 |
Anal pain | 1/66 (1.5%) | 1 |
Bloating | 3/66 (4.5%) | 6 |
Colitis | 1/66 (1.5%) | 1 |
Constipation | 32/66 (48.5%) | 54 |
Diarrhea | 52/66 (78.8%) | 87 |
Dry mouth | 19/66 (28.8%) | 42 |
Dyspepsia | 11/66 (16.7%) | 28 |
Dysphagia | 10/66 (15.2%) | 10 |
Esophageal pain | 1/66 (1.5%) | 1 |
Fecal incontinence | 3/66 (4.5%) | 3 |
Flatulence | 3/66 (4.5%) | 3 |
Gastritis | 2/66 (3%) | 2 |
Gastroesophageal reflux disease | 9/66 (13.6%) | 15 |
Gastrointestinal disorders - Other, specify | 12/66 (18.2%) | 22 |
Gastrointestinal pain | 1/66 (1.5%) | 1 |
Hemorrhoidal hemorrhage | 4/66 (6.1%) | 4 |
Hemorrhoids | 6/66 (9.1%) | 7 |
Ileus | 1/66 (1.5%) | 1 |
Mucositis oral | 47/66 (71.2%) | 56 |
Nausea | 48/66 (72.7%) | 111 |
Oral hemorrhage | 7/66 (10.6%) | 7 |
Oral pain | 11/66 (16.7%) | 14 |
Periodontal disease | 1/66 (1.5%) | 1 |
Proctitis | 1/66 (1.5%) | 1 |
Rectal hemorrhage | 1/66 (1.5%) | 1 |
Rectal pain | 3/66 (4.5%) | 4 |
Rectal ulcer | 1/66 (1.5%) | 1 |
Stomach pain | 1/66 (1.5%) | 1 |
Toothache | 1/66 (1.5%) | 1 |
Vomiting | 40/66 (60.6%) | 57 |
General disorders | ||
Chills | 21/66 (31.8%) | 30 |
Edema face | 7/66 (10.6%) | 8 |
Edema limbs | 24/66 (36.4%) | 56 |
Edema trunk | 3/66 (4.5%) | 3 |
Facial pain | 1/66 (1.5%) | 1 |
Fatigue | 50/66 (75.8%) | 155 |
Fever | 26/66 (39.4%) | 28 |
Flu like symptoms | 1/66 (1.5%) | 1 |
General disorders and administration site conditions - Other, specify | 5/66 (7.6%) | 5 |
Infusion related reaction | 5/66 (7.6%) | 7 |
Injection site reaction | 8/66 (12.1%) | 13 |
Localized edema | 2/66 (3%) | 2 |
Malaise | 1/66 (1.5%) | 1 |
Neck edema | 1/66 (1.5%) | 1 |
Non-cardiac chest pain | 12/66 (18.2%) | 16 |
Pain | 11/66 (16.7%) | 20 |
Hepatobiliary disorders | ||
Hepatobiliary disorders - Other, specify | 3/66 (4.5%) | 10 |
Immune system disorders | ||
Immune system disorders - Other, specify | 1/66 (1.5%) | 4 |
Infections and infestations | ||
Bladder infection | 3/66 (4.5%) | 4 |
Bronchial infection | 1/66 (1.5%) | 1 |
Catheter related infection | 1/66 (1.5%) | 1 |
Device related infection | 1/66 (1.5%) | 1 |
Enterocolitis infectious | 2/66 (3%) | 2 |
Infections and infestations - Other, specify | 29/66 (43.9%) | 46 |
Lip infection | 1/66 (1.5%) | 1 |
Lung infection | 6/66 (9.1%) | 8 |
Meningitis | 1/66 (1.5%) | 1 |
Mucosal infection | 6/66 (9.1%) | 16 |
Nail infection | 1/66 (1.5%) | 1 |
Papulopustular rash | 3/66 (4.5%) | 3 |
Rash pustular | 1/66 (1.5%) | 1 |
Sepsis | 5/66 (7.6%) | 7 |
Sinusitis | 1/66 (1.5%) | 4 |
Skin infection | 3/66 (4.5%) | 3 |
Soft tissue infection | 2/66 (3%) | 3 |
Tooth infection | 1/66 (1.5%) | 1 |
Upper respiratory infection | 7/66 (10.6%) | 8 |
Urinary tract infection | 4/66 (6.1%) | 5 |
Injury, poisoning and procedural complications | ||
Bruising | 12/66 (18.2%) | 21 |
Fall | 2/66 (3%) | 2 |
Injury, poisoning and procedural complications - Other, specify | 1/66 (1.5%) | 1 |
Spinal fracture | 1/66 (1.5%) | 1 |
Investigations | ||
Activated partial thromboplastin time prolonged | 7/66 (10.6%) | 15 |
Alanine aminotransferase increased | 40/66 (60.6%) | 99 |
Alkaline phosphatase increased | 23/66 (34.8%) | 48 |
Aspartate aminotransferase increased | 36/66 (54.5%) | 90 |
Blood bilirubin increased | 21/66 (31.8%) | 26 |
Cholesterol high | 1/66 (1.5%) | 1 |
Creatinine increased | 35/66 (53%) | 74 |
Fibrinogen decreased | 1/66 (1.5%) | 1 |
GGT increased | 3/66 (4.5%) | 10 |
INR increased | 6/66 (9.1%) | 11 |
Investigations - Other, specify | 4/66 (6.1%) | 32 |
Lymphocyte count decreased | 28/66 (42.4%) | 92 |
Neutrophil count decreased | 56/66 (84.8%) | 115 |
Platelet count decreased | 56/66 (84.8%) | 194 |
Weight gain | 3/66 (4.5%) | 5 |
Weight loss | 20/66 (30.3%) | 44 |
White blood cell decreased | 35/66 (53%) | 77 |
Metabolism and nutrition disorders | ||
Anorexia | 39/66 (59.1%) | 91 |
Dehydration | 8/66 (12.1%) | 9 |
Glucose intolerance | 1/66 (1.5%) | 1 |
Hypercalcemia | 5/66 (7.6%) | 10 |
Hyperglycemia | 54/66 (81.8%) | 156 |
Hyperkalemia | 24/66 (36.4%) | 36 |
Hypermagnesemia | 2/66 (3%) | 2 |
Hypernatremia | 5/66 (7.6%) | 5 |
Hypertriglyceridemia | 1/66 (1.5%) | 1 |
Hyperuricemia | 3/66 (4.5%) | 9 |
Hypoalbuminemia | 38/66 (57.6%) | 69 |
Hypocalcemia | 40/66 (60.6%) | 64 |
Hypoglycemia | 5/66 (7.6%) | 6 |
Hypokalemia | 33/66 (50%) | 45 |
Hypomagnesemia | 41/66 (62.1%) | 104 |
Hyponatremia | 36/66 (54.5%) | 72 |
Hypophosphatemia | 18/66 (27.3%) | 22 |
Metabolism and nutrition disorders - Other, specify | 12/66 (18.2%) | 37 |
Obesity | 1/66 (1.5%) | 6 |
Musculoskeletal and connective tissue disorders | ||
Arthralgia | 9/66 (13.6%) | 21 |
Arthritis | 1/66 (1.5%) | 7 |
Back pain | 14/66 (21.2%) | 29 |
Bone pain | 8/66 (12.1%) | 10 |
Buttock pain | 2/66 (3%) | 4 |
Flank pain | 4/66 (6.1%) | 7 |
Generalized muscle weakness | 21/66 (31.8%) | 41 |
Muscle weakness left-sided | 1/66 (1.5%) | 1 |
Muscle weakness lower limb | 2/66 (3%) | 2 |
Musculoskeletal and connective tissue disorder - Other, specify | 11/66 (16.7%) | 22 |
Myalgia | 7/66 (10.6%) | 12 |
Myositis | 1/66 (1.5%) | 1 |
Neck pain | 4/66 (6.1%) | 5 |
Osteoporosis | 1/66 (1.5%) | 1 |
Pain in extremity | 11/66 (16.7%) | 31 |
Nervous system disorders | ||
Akathisia | 2/66 (3%) | 2 |
Amnesia | 1/66 (1.5%) | 3 |
Dizziness | 16/66 (24.2%) | 24 |
Dysgeusia | 25/66 (37.9%) | 51 |
Encephalopathy | 1/66 (1.5%) | 1 |
Headache | 29/66 (43.9%) | 42 |
Hydrocephalus | 1/66 (1.5%) | 1 |
Hypersomnia | 1/66 (1.5%) | 1 |
Intracranial hemorrhage | 1/66 (1.5%) | 1 |
Lethargy | 4/66 (6.1%) | 4 |
Memory impairment | 2/66 (3%) | 3 |
Nervous system disorders - Other, specify | 1/66 (1.5%) | 1 |
Neuralgia | 1/66 (1.5%) | 2 |
Paresthesia | 2/66 (3%) | 3 |
Peripheral motor neuropathy | 5/66 (7.6%) | 6 |
Peripheral sensory neuropathy | 13/66 (19.7%) | 36 |
Presyncope | 1/66 (1.5%) | 1 |
Sinus pain | 3/66 (4.5%) | 4 |
Somnolence | 3/66 (4.5%) | 3 |
Stroke | 1/66 (1.5%) | 1 |
Syncope | 2/66 (3%) | 2 |
Transient ischemic attacks | 1/66 (1.5%) | 2 |
Tremor | 13/66 (19.7%) | 20 |
Vasovagal reaction | 1/66 (1.5%) | 1 |
Psychiatric disorders | ||
Agitation | 1/66 (1.5%) | 3 |
Anxiety | 18/66 (27.3%) | 39 |
Confusion | 13/66 (19.7%) | 14 |
Delirium | 1/66 (1.5%) | 1 |
Depression | 11/66 (16.7%) | 35 |
Hallucinations | 2/66 (3%) | 2 |
Insomnia | 24/66 (36.4%) | 54 |
Psychiatric disorders - Other, specify | 1/66 (1.5%) | 1 |
Renal and urinary disorders | ||
Acute kidney injury | 12/66 (18.2%) | 23 |
Bladder spasm | 2/66 (3%) | 2 |
Chronic kidney disease | 2/66 (3%) | 3 |
Cystitis noninfective | 2/66 (3%) | 2 |
Hematuria | 6/66 (9.1%) | 6 |
Proteinuria | 3/66 (4.5%) | 4 |
Renal and urinary disorders - Other, specify | 3/66 (4.5%) | 4 |
Renal calculi | 1/66 (1.5%) | 2 |
Urinary frequency | 10/66 (15.2%) | 18 |
Urinary incontinence | 3/66 (4.5%) | 3 |
Urinary retention | 5/66 (7.6%) | 6 |
Urinary tract obstruction | 1/66 (1.5%) | 2 |
Urinary tract pain | 7/66 (10.6%) | 8 |
Urinary urgency | 4/66 (6.1%) | 4 |
Reproductive system and breast disorders | ||
Genital edema | 3/66 (4.5%) | 3 |
Irregular menstruation | 1/66 (1.5%) | 1 |
Penile pain | 3/66 (4.5%) | 3 |
Prostatic obstruction | 1/66 (1.5%) | 1 |
Reproductive system and breast disorders - Other, specify | 1/66 (1.5%) | 2 |
Scrotal pain | 1/66 (1.5%) | 1 |
Vaginal discharge | 1/66 (1.5%) | 1 |
Vaginal dryness | 2/66 (3%) | 2 |
Vaginal hemorrhage | 1/66 (1.5%) | 1 |
Vaginal inflammation | 3/66 (4.5%) | 3 |
Respiratory, thoracic and mediastinal disorders | ||
Allergic rhinitis | 6/66 (9.1%) | 11 |
Atelectasis | 1/66 (1.5%) | 1 |
Bronchopulmonary hemorrhage | 1/66 (1.5%) | 1 |
Cough | 21/66 (31.8%) | 30 |
Dyspnea | 29/66 (43.9%) | 52 |
Epistaxis | 12/66 (18.2%) | 13 |
Hiccups | 5/66 (7.6%) | 5 |
Hypoxia | 9/66 (13.6%) | 9 |
Laryngeal hemorrhage | 2/66 (3%) | 2 |
Laryngeal mucositis | 1/66 (1.5%) | 1 |
Nasal congestion | 15/66 (22.7%) | 21 |
Pharyngeal mucositis | 3/66 (4.5%) | 4 |
Pleural effusion | 4/66 (6.1%) | 4 |
Pneumonitis | 2/66 (3%) | 2 |
Postnasal drip | 4/66 (6.1%) | 4 |
Productive cough | 3/66 (4.5%) | 3 |
Pulmonary edema | 4/66 (6.1%) | 4 |
Respiratory failure | 1/66 (1.5%) | 1 |
Respiratory, thoracic and mediastinal disorders - Other, specify | 7/66 (10.6%) | 9 |
Sneezing | 1/66 (1.5%) | 1 |
Sore throat | 16/66 (24.2%) | 24 |
Wheezing | 3/66 (4.5%) | 3 |
Skin and subcutaneous tissue disorders | ||
Alopecia | 5/66 (7.6%) | 16 |
Bullous dermatitis | 3/66 (4.5%) | 4 |
Dry skin | 21/66 (31.8%) | 43 |
Erythema multiforme | 5/66 (7.6%) | 11 |
Erythroderma | 1/66 (1.5%) | 2 |
Hyperhidrosis | 3/66 (4.5%) | 3 |
Nail loss | 3/66 (4.5%) | 9 |
Pain of skin | 6/66 (9.1%) | 8 |
Palmar-plantar erythrodysesthesia syndrome | 1/66 (1.5%) | 1 |
Pruritus | 31/66 (47%) | 50 |
Purpura | 3/66 (4.5%) | 4 |
Rash acneiform | 6/66 (9.1%) | 7 |
Rash maculo-papular | 34/66 (51.5%) | 58 |
Skin and subcutaneous tissue disorders - Other, specify | 20/66 (30.3%) | 55 |
Skin hyperpigmentation | 8/66 (12.1%) | 25 |
Skin hypopigmentation | 3/66 (4.5%) | 10 |
Skin ulceration | 8/66 (12.1%) | 12 |
Urticaria | 3/66 (4.5%) | 3 |
Surgical and medical procedures | ||
Surgical and medical procedures - Other, specify | 1/66 (1.5%) | 1 |
Vascular disorders | ||
Flushing | 2/66 (3%) | 2 |
Hot flashes | 2/66 (3%) | 2 |
Hypertension | 40/66 (60.6%) | 106 |
Hypotension | 21/66 (31.8%) | 39 |
Phlebitis | 1/66 (1.5%) | 1 |
Superficial thrombophlebitis | 1/66 (1.5%) | 1 |
Thromboembolic event | 7/66 (10.6%) | 21 |
Vascular disorders - Other, specify | 1/66 (1.5%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title | Ravi Vij, MD |
---|---|
Organization | Washington University School of Medicine |
Phone | |
rvij@im.wustl.edu |
- NCI-2011-02053
- NCI-2011-02053
- CDR0000681025
- CALGB-100801
- CALGB 100801
- CALGB-100801
- U10CA180821
- U10CA031946