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| Name | Class |
|---|---|
| Genzyme, a Sanofi Company | INDUSTRY |
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This phase I/II clinical trial will test the safety and the efficacy of post transplant administration of plerixafor in enhancing hematological recovery in humans. Patients who are appropriate candidates for myeloablative allogeneic stem cell transplantation from an HLA-matched sibling, matched unrelated donor or umbilical cord blood are eligible for enrollment. The investigators plan to enroll a total of 50 patients for this study (30 patients with HLA-matched sibling or matched unrelated donor transplant, and 20 patients with umbilical cord blood transplant). During phase I study, a small number of patients (3-6 patients from each group) will be enrolled to determine the safety of post transplant administration of plerixafor. Patients will receive plerixafor given at 240 µg/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment. Limiting toxicities are defined as primary or secondary graft failure, plerixafor-related severe premature ventricular arrhythmia or death. If safety criteria are met from the investigators phase I study, the investigators will proceed with phase II study to determine the efficacy of post transplant administration of plerixafor in enhancing haematological recovery. The experimental aspect of this study is the use of plerixafor and all other aspects of care will be in line with the standard of care. Both Phase I and Phase II patients will be combined for efficacy analysis, and data collected from this study will be compared with the investigators historical control. The results from this study will set the stage and provide the justification for a larger phase 3 trial.
Recruitment to this trial will be stratified by donor type as HLA (human leukocyte antigen) matched sibling, matched unrelated donor or umbilical cord blood. Patients will be conditioned with a myeloablative regimen such as, but not limited to, total body irradiation and cyclophosphamide. The donor stem cell grafts will come from mobilized peripheral blood of 8/8 or 7/8 HLA-identical family members, 8/8 (HLA A, B, C, DRBeta1) allele-level matched unrelated donors, or dual umbilical cord blood grafts with at least 4 of 6 HLA matching at HLA A and B (low resolution) and DRBeta1 (at high resolution). The target CD34+ cell dose will be 5 X 10(6)/kg recipient ideal body weight. For HLA matched sibling or matched unrelated donor (MUD) transplants, all patients will receive a minimum of 2 X 10(6) CD 24+ cells/kg. For cord blood transplants, each unit will contain a minimum total nucleated cell count of of 1.5 X 10(7)/kg. Post-transplant GVHD (graft versus host disease) prophylaxis will be given per institutional standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transplant Recipients | Experimental | Transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plerixafor | Drug | Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Neutrophil Recovery | leukocytes > 500/ul on 2 consecutive days | 100 Days post Transplant |
| Time to Platelet Recovery | platelet > 20,000/ul on 2 consecutive days | 100 Days Post Transplant |
| Plerixafor-associated Adverse Events | 100 Days Post Transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Transplant-related Mortality | 100 Days Post Transplant | |
| Absolute Lymphocyte Count at Day 90 | Cell reconstitution - absolute lymphocyte count at day 90 post transplant. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mitchell Horwitz, MD | Duke University | Principal Investigator |
| Saurabh Chhabra, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States | ||
| Medical University of South Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27535663 | Derived | Green MM, Chao N, Chhabra S, Corbet K, Gasparetto C, Horwitz A, Li Z, Venkata JK, Long G, Mims A, Rizzieri D, Sarantopoulos S, Stuart R, Sung AD, Sullivan KM, Costa L, Horwitz M, Kang Y. Plerixafor (a CXCR4 antagonist) following myeloablative allogeneic hematopoietic stem cell transplantation enhances hematopoietic recovery. J Hematol Oncol. 2016 Aug 17;9(1):71. doi: 10.1186/s13045-016-0301-2. |
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41 participants signed consent and 30 received transplant. 11 patients who signed consent were screen failures. Reasons patients did not receive transplant included lack of donor, insurance denial, too much disease, uncontrolled infection, class III or IV angina. 29 participants were used in results analysis because one participant withdrew.
Patients who are appropriate candidates for myeloablative allogeneic stem cell transplantation from an HLA-matched sibling, matched unrelated donor or umbilical cord blood are eligible for enrollment. The first subject was consented on 9/28/2011. The study closed to accrual on 5/27/2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Transplant Recipients | This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline includes transplant recipients only and excludes 1 patient who withdrew from the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Transplant Recipients | This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Time to Neutrophil Recovery | leukocytes > 500/ul on 2 consecutive days | Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed | Posted | Median | 95% Confidence Interval | days | 100 Days post Transplant |
|
|
adverse events are collected for 1 year post transplant
Adverse Events were monitored for 29 transplant recipients
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transplant Recipients | This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs. Adverse Events were monitored for 29 transplant recipients |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| encephalitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Brain (encephalitis, infectious) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adrenal insufficiency | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
Study was limited to recipients of matched adult donor grafts
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mitchell Horwitz, MD | Duke University Medical Center | 919-668-1045 | mitchel.horwitz@duke.edu |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
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|
| IL-12 at Day 30 | IL-12 at day 30; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation. | 30 days |
| Participants Experiencing Grade II-IV Acute Graft Versus Host Disease | We are reporting on the number of participants experiencing a grade II-IV acute graft versus host disease will be assessed weekly through Day 100 post transplant. Staging and grading of Acute GvHD is graded by pattern of organ involvement and clinical performance status using the Grading Index of Acute GvHD (Gluckman) and the Grading Index of Acute GVHD by the CIBMTR (Centers for International Blood and Marrow Transplant Research) | 100 days |
| CD3+ Cell Count at Day 90 | Cell reconstitution - CD3+ cell count at day 90 post transplant. This is a marker for the function of your immune system. | 90 Days |
| CD4 Cell Count at Day 90 | CD4 cell count at Day 90; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells. | 90 days |
| CD8 Cell Count at Day 90 | CD8 cell count at Day 90; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR). | 90 days |
| NK Cell Count at Day 90 | NK cell count at Day 90;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system. | 90 days |
| B Cell Count at Day 90 | B cell count at Day 90; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system. | 90 days |
| IFN Gamma at Day 30 | IFN gamma at day 30; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection. | 30 days |
| TNF-alpha at Day 30 | TNF-alpha at day 30; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells. | 30 days |
| CD4 Cell Count at Day 30 | CD4 cell count at Day 30; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells. | 30 days |
| CD4 Cell Count at Day 60 | CD4 cell count at Day 60; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells. | 60 days |
| CD8 Cell Count at Day 30 | CD8 cell count at Day 30; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR). | 30 days |
| CD8 Cell Count at Day 60 | CD8 cell count at Day 60; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR). | 60 days |
| NK Cell Count at Day 30 | NK cell count at Day 30;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system. | 30 days |
| NK Cell Count at Day 60 | NK cell count at Day 60;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system. | 60 days |
| B Cell Count at Day 30 | B cell count at Day 30; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system. | 30 days |
| B Cell Count at Day 60 | B cell count at Day 60; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system. | 60 days |
| IL-12 at Day 7 | IL-12 at day 7; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation. | 7 days |
| IL-12 at Day 14 | IL-12 at day 14; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation. | 14 days |
| IFN Gamma at Day 7 | IFN gamma at day 7; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection. | 7 days |
| IFN Gamma at Day 14 | IFN gamma at day 14; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection. | 14 days |
| TNF-alpha at Day 7 | TNF-alpha at day 7; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells. | 7 days |
| TNF-alpha at Day 14 | TNF-alpha at day 14; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells. | 14 days |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | Time to Platelet Recovery | platelet > 20,000/ul on 2 consecutive days | Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed | Posted | Median | 95% Confidence Interval | days | 100 Days Post Transplant |
|
|
|
| Primary | Plerixafor-associated Adverse Events | Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed | Posted | Number | number of adverse events | 100 Days Post Transplant |
|
|
|
| Secondary | Transplant-related Mortality | Out of the 30 transplant recipients, one participant withdrew and was therefore not analyzed | Posted | Number | participants | 100 Days Post Transplant |
|
|
|
| Secondary | Absolute Lymphocyte Count at Day 90 | Cell reconstitution - absolute lymphocyte count at day 90 post transplant. | the population includes all participants for which we have data at day 90 | Posted | Median | Full Range | number of lymphocytes | 90 days |
|
|
|
| Secondary | IL-12 at Day 30 | IL-12 at day 30; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation. | the population includes all participants for which we have data at day 30 | Posted | Median | Full Range | pg/mL | 30 days |
|
|
|
| Secondary | Participants Experiencing Grade II-IV Acute Graft Versus Host Disease | We are reporting on the number of participants experiencing a grade II-IV acute graft versus host disease will be assessed weekly through Day 100 post transplant. Staging and grading of Acute GvHD is graded by pattern of organ involvement and clinical performance status using the Grading Index of Acute GvHD (Gluckman) and the Grading Index of Acute GVHD by the CIBMTR (Centers for International Blood and Marrow Transplant Research) | Posted | Number | participants | 100 days |
|
|
|
| Secondary | CD3+ Cell Count at Day 90 | Cell reconstitution - CD3+ cell count at day 90 post transplant. This is a marker for the function of your immune system. | the population includes all participants for which we have data at day 90 | Posted | Median | Full Range | number of CD3+ cells | 90 Days |
|
|
|
| Secondary | CD4 Cell Count at Day 90 | CD4 cell count at Day 90; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells. | The population includes subjects for which we have data at day 90. | Posted | Median | Full Range | number of CD4 cells | 90 days |
|
|
|
| Secondary | CD8 Cell Count at Day 90 | CD8 cell count at Day 90; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR). | the population includes subjects for which we have data at day 90 | Posted | Median | Full Range | number of CD8 cells | 90 days |
|
|
|
| Secondary | NK Cell Count at Day 90 | NK cell count at Day 90;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system. | the population includes subjects for which we have data at Day 90. | Posted | Median | Full Range | number of NK cells | 90 days |
|
|
|
| Secondary | B Cell Count at Day 90 | B cell count at Day 90; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system. | the population includes subjects for which we have data at Day 90. | Posted | Median | Full Range | number of B cells | 90 days |
|
|
|
| Secondary | IFN Gamma at Day 30 | IFN gamma at day 30; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection. | the population includes subject for which we have data at Day 30. | Posted | Median | Full Range | pg/mL | 30 days |
|
|
|
| Secondary | TNF-alpha at Day 30 | TNF-alpha at day 30; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells. | the population includes subject for which we have data at Day 30. | Posted | Median | Full Range | pg/mL | 30 days |
|
|
|
| Secondary | CD4 Cell Count at Day 30 | CD4 cell count at Day 30; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells. | The population includes subjects for which we have data at day 30. | Posted | Median | Full Range | number of CD4 cells | 30 days |
|
|
|
| Secondary | CD4 Cell Count at Day 60 | CD4 cell count at Day 60; CD4+ T helper cells are white blood cells that are an essential part of the human immune system. They are often referred to as CD4 cells, T-helper cells or T4 cells. | The population includes subjects for which we have data at day 30. | Posted | Median | Full Range | number of CD4 cells | 60 days |
|
|
|
| Secondary | CD8 Cell Count at Day 30 | CD8 cell count at Day 30; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR). | the population includes subjects for which we have data at day 30 | Posted | Median | Full Range | number of CD8 cells | 30 days |
|
|
|
| Secondary | CD8 Cell Count at Day 60 | CD8 cell count at Day 60; CD8 (cluster of differentiation 8) is a transmembrane glycoprotein that serves as a co-receptor for the T cell receptor (TCR). | the population includes subjects for which we have data at day 60 | Posted | Median | Full Range | number of CD8 cells | 60 days |
|
|
|
| Secondary | NK Cell Count at Day 30 | NK cell count at Day 30;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system. | the population includes subjects for which we have data at Day 30. | Posted | Median | Full Range | number of NK cells | 30 days |
|
|
|
| Secondary | NK Cell Count at Day 60 | NK cell count at Day 60;Natural killer cells or NK cells are a type of cytotoxic lymphocyte critical to the immune system. | the population includes subjects for which we have data at Day 60. | Posted | Median | Full Range | number of NK cells | 60 days |
|
|
|
| Secondary | B Cell Count at Day 30 | B cell count at Day 30; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system. | the population includes subjects for which we have data at Day 30. | Posted | Median | Full Range | number of B cells | 30 days |
|
|
|
| Secondary | B Cell Count at Day 60 | B cell count at Day 60; B cells, also known as B lymphocytes, are a type of white blood cell of the lymphocyte subtype and they function as part of the immune system. | the population includes subjects for which we have data at Day 60. | Posted | Median | Full Range | number of B cells | 60 days |
|
|
|
| Secondary | IL-12 at Day 7 | IL-12 at day 7; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation. | the population includes all participants for which we have data at day 7 | Posted | Median | Full Range | pg/mL | 7 days |
|
|
|
| Secondary | IL-12 at Day 14 | IL-12 at day 14; Interleukin 12 (IL-12) is an interleukin that is naturally produced by dendritic cells, macrophages, neutrophils, and human B-lymphoblastoid cells (NC-37) in response to antigenic stimulation. | the population includes all participants for which we have data at day 14 | Posted | Median | Full Range | pg/mL | 14 days |
|
|
|
| Secondary | IFN Gamma at Day 7 | IFN gamma at day 7; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection. | the population includes subject for which we have data at Day 7. | Posted | Median | Full Range | pg/mL | 7 days |
|
|
|
| Secondary | IFN Gamma at Day 14 | IFN gamma at day 14; Interferon gamma (IFNγ) is a dimerized soluble cytokine that is the only member of the type II class of interferons which are important for immunity against infection. | the population includes subject for which we have data at Day 14. | Posted | Median | Full Range | pg/mL | 14 days |
|
|
|
| Secondary | TNF-alpha at Day 7 | TNF-alpha at day 7; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells. | the population includes subject for which we have data at Day 7. | Posted | Median | Full Range | pg/mL | 7 days |
|
|
|
| Secondary | TNF-alpha at Day 14 | TNF-alpha at day 14; Tumor necrosis factor is a cell signaling protein (cytokine) involved in systemic inflammation and is one of the cytokines that make up the acute phase reaction. The primary role of TNF is in the regulation of immune cells. | the population includes subject for which we have data at Day 14. | Posted | Median | Full Range | pg/mL | 14 days |
|
|
|
| 12 |
| 29 |
| 29 |
| 29 |
|
| death | General disorders | CTCAE (4.0) | Systematic Assessment | Death Not Associated with CTCAE term - Death NOS |
|
| pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Lung (pneumonia) |
|
| small bowel (NOS) | Infections and infestations | CTCAE (4.0) | Systematic Assessment | Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L) - Small bowel NOS |
|
| death | General disorders | CTCAE (4.0) | Systematic Assessment | Death Not Associated with CTCAE term - Disease Progression NOS |
|
| death | General disorders | CTCAE (4.0) | Systematic Assessment | Death Not Associated with CTCAE term - Multi-Organ Failure |
|
| Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| hypogammagloulinemia | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| AST, SGOT (serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| presbyacusis (Hearing loss) | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bladder spasms | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| engraftment syndrome | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| pancytopenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| relapsed disease | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| tacycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Confusion | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| pyrexia (fever) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| frail appearance | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| hyperthermia (overheating) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Creatinine | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dental: caries | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| contact dermatitis | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| groin irratation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| pallor | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| scratch marks | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| purpuric lesion | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| perianal lesion | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| keratoconjunctivitis (Dry Eye Syndrome) | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth / salivary gland (xerostomia) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| xeroderma (Dry Skin) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Extremity-lower (gait / walking) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| odynophagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| oropharyngeal erythema | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| pain - general body ache | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hair Loss / Alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hearing Loss | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Heartburn / dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemoglobin | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhage, pulmonary / upper respiratory | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| hyperbilirubinemia | Hepatobiliary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hiccoughs (hiccups, singultus) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| viremia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| rsv pneumonia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection with unknown ANC - Blood | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection with unknown ANC - Lung (pneumonia) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection with unknown ANC - Sinus | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection with unknown ANC - Skin (cellulitis) | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection with unknown ANC - Urinary tract NOS | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Infection without febrile neutropenia | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Leukocytes (total WBC) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mental status decrease | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mood Alteration - Anxiety | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| pain - headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis / Stomatitis (clinical exam) | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Muscle weakness, generalized or specific area (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| asthenia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Musculoskeletal / Soft Tissue injury | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal cavity / paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neurology | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| fall | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| lethargy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| peripheral neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophils / granulocytes (ANC / AGC) | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| subconjunctivial hemorrhage | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| rheum (crusty eye) | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Otitis, middle ear (non-infectious) | Ear and labyrinth disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Abdomen NOS | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Back | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Bone | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Chest / thorax NOS | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Head / headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Joint | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain- groin | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Ovulatory | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain - Throat / pharynx / larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| platelets | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis / pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Potassium, serum-low (hypokalemia) | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus / itching | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary / Upper Respiratory infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash / desquamation | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash: acne / acneiform | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rigors / chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus Tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Taste Alteration (dysgeusia) | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombosis / embolism (vascular access-related) | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thrombotic microangiopathy | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Thyroid function, low (hypothyroidism) | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| polyuria (Urinary frequency / urgency) | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vision - blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| photophobia | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Watery eye (epiphora, tearing) | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Weight gain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
|
| fatigue |
|
| rash |
|
| pneumonia |
|
| bruising |
|