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This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.
In this study, we are seeking to target the leukemia microenvironment to overcome disease resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic chemotherapy. In this study, we seek to maximize blockage of the SDF-1/CXCR4 axis through the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental |
|
|
| Dose Level 2 | Experimental |
|
|
| Dose Level 3 | Experimental |
|
|
| Dose Level 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC | Completion of Phase I enrollment (17 months) | |
| Phase II: Complete Response Rate (CR+CRi) |
| 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I and Phase II: Safety and Tolerability of Regimen as Measured by Grade and Frequency of Adverse Events Exceeding 10% in Total Frequency | 30 days following end of treatment | |
| Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery |
Not provided
Inclusion Criteria:
Acute myeloid leukemia diagnosed by WHO criteria with one of the following:
Age between 18 and 70 years old
ECOG performance status ≤ 3
Adequate organ function defined as:
Are surgically or biologically sterile or willing to practice acceptable birth control, as follows:
Able to provide signed informed consent prior to registration on study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey L. Uy, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | United States | ||
| Washington University |
Not provided
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
Not provided
Not provided
The study opened to participant enrollment on 02/04/2011 and closed to participant enrollment on 08/19/2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1 |
|
| FG001 | Dose Level 2 |
|
| FG002 | Dose Level 3 |
|
| FG003 | Dose Level 4 |
|
| FG004 | Dose Level 5 |
|
| FG005 | MTD - Phase II |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 |
|
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Phase I: Maximum Tolerated Dose of Plerixafor Plus G-CSF When Combined With MEC | Number of participants analyzed is the number of participants enrolled in the Phase I portion of the study. | Posted | Number | mcg/kg/day | Completion of Phase I enrollment (17 months) |
|
|
Not provided
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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 | Dose Level 1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Body pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal cramping | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geoffrey Uy, M.D. | Washington University School of Medicine | 314-454-8304 | guy@wustl.edu |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| C088327 | plerixafor |
| D008942 | Mitoxantrone |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
Not provided
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|
| Dose Level 5 | Experimental |
|
|
| MTD - Phase II | Experimental |
|
|
| Plerixafor | Drug |
|
|
| Mitoxantrone | Drug |
|
|
| Etoposide | Drug |
|
|
| Cytarabine | Drug |
|
|
-Neutrophil recovery is defined as absolute neutrophil count (ANC) >= 500/mm^3
| Up to 62 days after treatment |
| Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery | -Neutrophil recovery is defined as absolute neutrophil count >= 1000/mm^3 | Up to 62 days after treatment |
| Time to Hematologic Recovery as Measured by Time to Platelet Recovery | -Platelet recovery is defined as platelets >= 50,000/mm^3 | Up to 62 days after treatment |
| Time to Hematologic Recovery as Measured by Time to Platelet Recovery | -Platelet recovery is defined as platelets >= 100,000/mm3 | Up to 62 days after treatment |
| Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in White Blood Cells | 6 hours after plerixafor |
| Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in AML Blast Count | 6 hours after plerixafor |
| Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 1D9 Relative Mean Fluorescent Intensity | 6 hours after plerixafor |
| Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 12G5 Relative Mean Fluorescent Intensity | 6 hours after plerixafor |
| Time to Progression | Recurrence / morphologic relapse: Defined as reappearance of blasts in the blood or the finding of > 5% blasts in the BM, not attributable to any other cause. New dysplastic changes are considered a relapse. If there are no blasts in the peripheral blood and 5-19% blasts in the BM, the BM biopsy and aspirate should be repeated in > 1 week to confirm relapse. | 2 years |
| Time to Treatment Failure | 8 days |
| Overall Survival | Overall survival: Defined as the date of first dose of study drug to the date of death from any cause. | Median follow-up was 34.6 months |
| St Louis |
| Missouri |
| 63110 |
| United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Physician Decision |
|
| Dose Level 2 |
|
| BG002 | Dose Level 3 |
|
| BG003 | Dose Level 4 |
|
| BG004 | Dose Level 5 (Includes MTD-Phase II) |
|
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Phase II: Complete Response Rate (CR+CRi) |
| Only patients enrolled in Phase 2 portion were analyzed for this outcome measure. | Posted | Number | percentage of participants | 45 days |
|
|
|
| Secondary | Phase I and Phase II: Safety and Tolerability of Regimen as Measured by Grade and Frequency of Adverse Events Exceeding 10% in Total Frequency | Posted | Number | number of events | 30 days following end of treatment |
|
|
|
| Secondary | Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery | -Neutrophil recovery is defined as absolute neutrophil count (ANC) >= 500/mm^3 | All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi whose ANC was >=500/mm^3 were evaluable for this outcome measure. | Posted | Median | Full Range | days | Up to 62 days after treatment |
|
|
|
| Secondary | Time to Hematologic Recovery as Measured by Time to Neutrophil Recovery | -Neutrophil recovery is defined as absolute neutrophil count >= 1000/mm^3 | All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi whose ANC was >=1000/mm^3 were evaluable for this outcome measure. | Posted | Median | Full Range | days | Up to 62 days after treatment |
|
|
|
| Secondary | Time to Hematologic Recovery as Measured by Time to Platelet Recovery | -Platelet recovery is defined as platelets >= 50,000/mm^3 | All participants enrolled in the study (both Phase I or Phase II) who had CR whose platelets were >=50,000/mm^3 were evaluable for this outcome measure. | Posted | Median | Full Range | days | Up to 62 days after treatment |
|
|
|
| Secondary | Time to Hematologic Recovery as Measured by Time to Platelet Recovery | -Platelet recovery is defined as platelets >= 100,000/mm3 | All participants enrolled in the study (both Phase I or Phase II) who had a CR whose platelets were >=100,000/mm^3 were evaluable for this outcome measure. | Posted | Median | Full Range | days | Up to 62 days after treatment |
|
|
|
| Secondary | Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in White Blood Cells | 31 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 4 patients did not have usable peripheral blood samples for this outcome measure. | Posted | Mean | Standard Deviation | fold change in white blood cells | 6 hours after plerixafor |
|
|
|
| Secondary | Characterize the Mobilization of Leukemic Cells With Plerixafor Plus G-CSF as Measured by Fold Change in AML Blast Count | 31 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 4 patients did not have usable peripheral blood samples for this outcome measure. | Posted | Mean | Standard Deviation | fold change in AML blast count | 6 hours after plerixafor |
|
|
|
| Secondary | Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 1D9 Relative Mean Fluorescent Intensity | 29 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 6 patients did not have usable peripheral blood samples for this outcome measure. | Posted | Mean | Standard Deviation | fold change in CXCR4 clone 1D9 | 6 hours after plerixafor |
|
|
|
| Secondary | Characterize the Effects of Plerixafor Plus G-CSF on Fold Change in CXCR4 Clone 12G5 Relative Mean Fluorescent Intensity | 29 patients were evaluable for this outcome measure (3 patients were never treated due to being ineligible and 1 patient never treated due to physician decision). The remaining 6 patients did not have usable peripheral blood samples for this outcome measure. | Posted | Mean | Standard Deviation | fold change in CXCR4 clone 1D9 | 6 hours after plerixafor |
|
|
|
| Secondary | Time to Progression | Recurrence / morphologic relapse: Defined as reappearance of blasts in the blood or the finding of > 5% blasts in the BM, not attributable to any other cause. New dysplastic changes are considered a relapse. If there are no blasts in the peripheral blood and 5-19% blasts in the BM, the BM biopsy and aspirate should be repeated in > 1 week to confirm relapse. | Data was not collected for this outcome measure. Progression is very hard to define acute myeloid leukemia and including it as a pre-specified secondary outcome measure in the protocol was an oversight. | Posted | 2 years |
|
|
| Secondary | Time to Treatment Failure | Data was not collected for this outcome measure. It is not well defined in the literature as when to measure treatment failure. Relapse free survival is a better way to measure response duration (this outcome measure was added to the results). | Posted | 8 days |
|
|
| Secondary | Overall Survival | Overall survival: Defined as the date of first dose of study drug to the date of death from any cause. | Posted | Median | Full Range | days | Median follow-up was 34.6 months |
|
|
|
| Post-Hoc | Relapse Free-survival Rate | All participants enrolled in the study (both Phase I or Phase II) who had a CR/CRi were evaluable for this outcome measure. | Posted | Number | percentage of participants | 2 years |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Dose Level 2 |
| 2 | 3 | 3 | 3 |
| EG002 | Dose Level 3 |
| 0 | 3 | 3 | 3 |
| EG003 | Dose Level 4 |
| 2 | 6 | 6 | 6 |
| EG004 | Dose Level 5 |
| 2 | 6 | 6 | 6 |
| EG005 | MTD - Phase II |
| 2 | 14 | 14 | 14 |
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cardiac troponin increased | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Subdural hematoma | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Alkaline phosphatase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Allergic reaction | Immune system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fungemia - Candida parapsilosis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bacteremia - Corynebacterium Species | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bacteremia - Klebsiella | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bacteremia - Staphylococcus epidermis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bacteremia - Streptococcus agalactiae | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Delirium | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Double uterus | Congenital, familial and genetic disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysesthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysphasia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Edema: limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Enlarged bladder | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Enterocolitis infectious | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Esophageal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Fecal incontinence | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Floaters | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Graft versus host disease | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hallucinations | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hematuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hot flashes | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypernatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypersomnia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| INR increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Inclusion cyst - mid thoracic back | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (4.0) | Systematic Assessment |
|
| Increased creatinine | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (4.0) | Systematic Assessment |
|
| Laryngeal hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Lip infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lung infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral dysesthesia | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pain | General disorders | CTCAE (4.0) | Systematic Assessment |
|
| Papulopustular rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Perirectal abscess | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Perirectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pleural hemmorhage | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Rectal ulcer | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Scalp pain | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
|
| Skin infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Skin ulceration | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Stroke | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Subconjunctival hemorrhage | Eye disorders | CTCAE (4.0) | Systematic Assessment |
|
| Subdural hematoma | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Submandibular mass | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
| Tumor lysis syndrome | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE (4.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| White blood cell decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
| Intracranial hemorrhage | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| Febrile neutropenia |
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| Abdominal pain |
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| Constipation |
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| Diarrhea |
|
| Gastroesophageal reflux disease |
|
| Mucositis oral |
|
| Nausea |
|
| Vomiting |
|
| Chills |
|
| Edema-limbs |
|
| Fatigue |
|
| Fever |
|
| Non-cardiac chest pain |
|
| Pain |
|
| Bacteremia |
|
| Lung infection |
|
| Sepsis |
|
| Activated partial thromboplastin time prolonged |
|
| Alanine aminotransferase increased |
|
| Alkaline phosphatase increased |
|
| Aspartate aminotransferase increased |
|
| Blood bilirubin increased |
|
| INR increased |
|
| Neutrophil count decreased |
|
| Platelet count decreased |
|
| White blood cell count decreased |
|
| Anorexia |
|
| Hypoalbuminemia |
|
| Hypocalcemia |
|
| Hypokalemia |
|
| Hypomagnesemia |
|
| Hyponatremia |
|
| Bone pain |
|
| Dizziness |
|
| Headache |
|
| Paresthesia |
|
| Insomnia |
|
| Proteinuria |
|
| Cough |
|
| Dyspnea |
|
| Pneumonitis |
|
| Rash maculo-papular |
|
| Hypotension |
|