| ID | Type | Description | Link |
|---|---|---|---|
| 03-C-0304 |
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Background:
The paradigm of combining therapeutic agents with non-overlapping toxicities for the treatment of malignancy produces clinical remissions and cures in a number of tumor types.
A new class of agents, humanized and chimerized monoclonal antibodies, typically have little or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic chemotherapy. It has become clear that in certain lymphomas and breast cancers, the combination of monoclonal antibodies and chemotherapy improves response rate and the quality of the response compared with that achieved by treatment with either agent alone.
The clinical outcome for patients with T-cell non-Hodgkins lymphoma is significantly inferior to the outcome of patients with B-cell non-Hodgkin s lymphoma. In most reports less than 20% of patients with T cell lymphoid malignancies remain free of disease at 5 years.
Objectives:
Determine the toxicity of Alemtuzumab and etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy in untreated cluster of differentiation 52 (CD52)-expressing T and natural killer (NK) lymphoid malignancies.
Determine the maximum tolerated dose of Alemtuzumab administered in combination with EPOCH chemotherapy.
Determine in a preliminary fashion the anti-tumor activity of the combination of Alemtuzumab and EPOCH chemotherapy.
Eligibility:
CD52-expressing lymphoid malignancy.
Patients with chemotherapy naive aggressive T & NK lymphomas. Patients with alk-positive anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible.
Age greater than or equal to 17 years.
Adequate organ function, unless impairment due to respective organ involvement by tumor.
No active symptomatic ischemic heart disease, myocardial infarction or congestive heart. failure within the past year.
Human immunodeficiency virus (HIV) negative.
Not pregnant or nursing.
Design:
Three dose levels of Alemtuzumab will be evaluated to determine the toxicity profile and in a preliminary fashion the antitumor activity of the combination with Dose-Adjusted EPOCH.
Three dose levels of Alemtuzumab will be explored, in cohorts of three to six patients each. Patients will receive either 30, 60, or 90 mg of Alemtuzumab on day 1 of therapy, followed by dose-adjusted EPOCH chemotherapy days 1-5.
Background:
The paradigm of combining therapeutic agents with non-overlapping toxicities for the treatment of malignancy produces clinical remissions and cures in a number of tumor types.
A new class of agents, humanized and chimerized monoclonal antibodies, typically have little or no hematopoietic toxicity and can be readily combined with full doses of cytotoxic chemotherapy. It has become clear that in certain lymphomas and breast cancers, the combination of monoclonal antibodies and chemotherapy improves response rate and the quality of the response compared with that achieved by treatment with either agent alone.
The clinical outcome for patients with T-cell non-Hodgkins lymphoma is significantly inferior to the outcome of patients with B-cell non-Hodgkins lymphoma. In most reports less than 20% of patients with T cell lymphoid malignancies remain free of disease at 5 years.
Objective:
Determine the toxicity and maximum tolerated dose (MTD) of Alemtuzumab and EPOCH chemotherapy in untreated cluster of differentiation 52 (CD52)-expressing T and natural killer (NK) lymphoid malignancies
Eligibility:
Design:
Three dose levels of Alemtuzumab will be evaluated to determine the toxicity profile and in a preliminary fashion the antitumor activity of the combination with Dose-Adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH).
Three dose levels of Alemtuzumab will be explored, in cohorts of three to six patients each. Patients will receive either 30, 60, or 90 mg of Alemtuzumab on day 1 of therapy, followed by dose-adjusted EPOCH chemotherapy days 1-5.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alemtuzumab Dose Escalation | Experimental | Alemtuzumab (Campath) followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) every 3 weeks for up to 6 cycles. Three cohorts of 3 to 6 patients will be treated. Cohort 1 will receive 30mg of Alemtuzumab, cohort 2 will receive 60mg of Alemtuzumab, and cohort 3 will receive 90mg of Alemtuzumab. If 1 of 3 participants entered at a given dose level experiences dose limiting toxicity (DLT), up to 3 additional participants will be entered at that dose level. If 2 of 6 participants experience DLT at a particular dose level, the maximum tolerated dose (MTD) has been exceeded. The preceding dose level will be the MTD, provided 6 participants have been entered at this level and no more than 1 has experienced DLT. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alemtuzumab (Campath) | Biological | Alemtuzumab (Campath) followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) every 3 weeks for up to 6 cycles. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose (MTD) of Alemtuzumab | MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously up to 2 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT). | up to 2 cycles of therapy, approximately 42 days |
| Number of Participants With Adverse Events | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. | 67 months and 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response | Response was measured by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (Cru)is as per complete remission criterion except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response (PR) is ≥50% decrease in the SPD of 6 largest dominant nodes or nodal masses. Progressive disease (PD) is ≥50% increase from the nadir in the SPD of any previously identified abnormal node for PRS or non-responders. Stable disease (SD) is less than a PR but not progressive disease. |
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Cluster of differentiation 52 (CD52)-expressing lymphoid malignancy, confirmed by pathology or flow cytometry staff of the Hematopathology Section, Laboratory of Pathology, National Cancer Institute (NCI). Patients with T & natural killer (NK) cell malignancy without accessible tissue for flow cytometry analysis may be treated on this study.
Patients with chemotherapy naive aggressive T & NK lymphomas, including but not limited to peripheral T cell lymphoma (not otherwise specified (nos)), gamma-delta hepatosplenic T cell lymphoma, subcutaneous panniculitis-like T cell, NK-T cell lymphoma confirmed by pathology or flow cytometry staff of the Hematopathology Section, Laboratory of Pathology, NCI. Patients with alk-positive anaplastic large cell lymphoma and patients with T cell precursor disease are not eligible.
Age greater than or equal to 17 years.
Laboratory tests: Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 ml/min; bilirubin less than 2.0 mg/dl unless due to Gilbert's, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 times upper limit of normal (ULN) (AST and ALT is less than or equal to 6 times ULN for patients on hyperalimentation for whom these abnormalities are felt to be due to the hyperalimentation) and; absolute neutrophil count (ANC) is greater than or equal to 1000/mm(3), platelet greater than or equal to 75,000/mm(3); unless impairment due to respective organ involvement by tumor.
No active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year.
Human immunodeficiency virus (HIV) negative, because of the unknown effects of combined therapy with chemotherapy and an immunosuppressive agent on HIV progression.
Signed informed consent.
Willing to use contraception.
Not pregnant or nursing, because of the unknown effects of Alemtuzumab on the developing fetus and infant.
No serious underlying medical condition or infection that would contraindicate treatment. Patients with central nervous system (CNS) involvement are eligible for treatment on this study.
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| Name | Affiliation | Role |
|---|---|---|
| Wyndham H Wilson, M.D. | National Cancer Institute (NCI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8981930 | Background | Wing MG, Moreau T, Greenwood J, Smith RM, Hale G, Isaacs J, Waldmann H, Lachmann PJ, Compston A. Mechanism of first-dose cytokine-release syndrome by CAMPATH 1-H: involvement of CD16 (FcgammaRIII) and CD11a/CD18 (LFA-1) on NK cells. J Clin Invest. 1996 Dec 15;98(12):2819-26. doi: 10.1172/JCI119110. | |
| 8068936 | Background |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Alemtuzumab 30 mg | Alemtuzumab (Campath) 30mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles. |
| FG001 | Alemtuzumab 60 mg | Alemtuzumab (Campath) 60mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles. |
| FG002 | Alemtuzumab 90 mg | Alemtuzumab (Campath) 90mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 - Dose Level 1 (Weeks 1 - 18) |
|
| ||||||||||||||||||
| Cohort 2 - Dose Level 2 (Weeks 1-18) |
| |||||||||||||||||||
| Cohort 3 - Dose Level 3 (Weeks 1-18) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles. |
| 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 | Maximum Tolerated Dose (MTD) of Alemtuzumab | MTD was achieved by increasing doses of Alemtuzumab on three cohorts. Cohort 1 received 30mg of Alemtuzumab, cohort 2 received 60mg of Alemtuzumab, and cohort 3 received 90mg of Alemtuzumab intravenously up to 2 cycles. The MTD reflects the highest dose of Alemtuzumab in which no more than 1 of 6 participants entered at a specific dose level experienced a dose limiting toxicity (DLT). | Posted | Number | mg | up to 2 cycles of therapy, approximately 42 days |
|
67 months and 9 days
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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 | All Participants | All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles. The adverse events are not reported per dose level because we normally look at all adverse events together irrespective of the dose level. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DEATH:: Death related to the study | General disorders | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALLERGY/IMMUNOLOGY:: Allergic reaction/hypersensitivity (including drug fever) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wyndham WIlson | National Cancer Institute | 301-435-2415 | wilsonw@mail.nih.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 16, 2018 | Feb 1, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2020 | Feb 1, 2021 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D005047 | Etoposide |
| D011241 | Prednisone |
| D014750 | Vincristine |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| EPOCH | Drug | Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) + Alemtuzumab (Campath) every 3 weeks for up to 6 cycles. |
|
|
| From date of onstudy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 67 months and 9 days. |
| Harris NL, Jaffe ES, Stein H, Banks PM, Chan JK, Cleary ML, Delsol G, De Wolf-Peeters C, Falini B, Gatter KC, et al. A revised European-American classification of lymphoid neoplasms: a proposal from the International Lymphoma Study Group. Blood. 1994 Sep 1;84(5):1361-92. No abstract available. |
| 9166827 | Background | A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's Lymphoma Classification Project. Blood. 1997 Jun 1;89(11):3909-18. |
| 35882475 | Derived | Lai C, Cole DE, Steinberg SM, Lucas N, Dombi E, Melani C, Roschewski M, Balis F, Widemann BC, Wilson WH. Doxorubicin pharmacokinetics and toxicity in patients with aggressive lymphoma and hepatic impairment. Blood Adv. 2023 Feb 28;7(4):529-532. doi: 10.1182/bloodadvances.2022007431. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Number of Participants With Adverse Events | Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. | Posted | Count of Participants | Participants | 67 months and 9 days |
|
|
|
| Secondary | Clinical Response | Response was measured by the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas. Complete remission (CR) is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed (Cru)is as per complete remission criterion except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response (PR) is ≥50% decrease in the SPD of 6 largest dominant nodes or nodal masses. Progressive disease (PD) is ≥50% increase from the nadir in the SPD of any previously identified abnormal node for PRS or non-responders. Stable disease (SD) is less than a PR but not progressive disease. | Posted | Count of Participants | Participants | From date of onstudy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 67 months and 9 days. |
|
|
|
| 23 |
| 31 |
| 23 |
| 31 |
| 31 |
| 31 |
| DEATH:: Death due to progression | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Upper GI Not otherwise specified (NOS) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION:: Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| INFECTION:: Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L):: Blood |
|
| INFECTION:: Infection (documented clinically or microbiologically) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L):: Brain (encephalitis, infectious) |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Lung (pneumonia) |
|
| INFECTION:: Infection with unknown ANC:: Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| RENAL/GENITOURINARY:: Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| RENAL/GENITOURINARY:: Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| AUDITORY/EAR:: Otitis, middle ear (non-infectious) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| AUDITORY/EAR:: Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Bone marrow cellularity | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Hemoglobin | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Leukocytes (total white blood count (WBC)) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Absolute neutrophil count/absolute granulocyte count (ANC/AGC) |
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| BLOOD/BONE MARROW:: Platelets | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| CARDIAC ARRHYTHMIA:: Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus bradycardia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Supraventricular arrhythmia NOS | General disorders | CTCAE (3.0) | Systematic Assessment | Not otherwise specified (NOS) |
|
| CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Supraventricular tachycardia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| CARDIAC ARRHYTHMIA:: Vasovagal episode | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| CARDIAC GENERAL:: Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| CARDIAC GENERAL:: Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| COAGULATION:: PTT (Partial Thromboplastin Time) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| CONSTITUTIONAL SYMPTOMS | General disorders | CTCAE (3.0) | Systematic Assessment | Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) |
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| CONSTITUTIONAL SYMPTOMS:: Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment |
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| CONSTITUTIONAL SYMPTOMS:: Rigors/chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| CONSTITUTIONAL SYMPTOMS:: Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Specify, excoriation) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Flushing | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Hair loss/alopecia (scalp or body) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Hyperpigmentation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Nail changes | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Pruritus/itching | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Rash/desquamation | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| DERMATOLOGY/SKIN:: Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Dental: teeth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| GASTROINTESTINAL:: Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Dry mouth/salivary gland (xerostomia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Esophagitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| GASTROINTESTINAL:: Flatulence | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Gastritis (including bile reflux gastritis) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Gastrointestinal - Other (Specify, duodenitis) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Mucositis/stomatitis (clinical exam):: Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Mucositis/stomatitis (clinical exam):: Pharynx | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Esophagus | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Proctitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Taste alteration (dysgeusia) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Typhlitis (cecal inflammation) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Lower GI NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Not otherwise specified (NOS) |
|
| HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Oral cavity | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Upper GI NOS | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Bladder | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Genitourinary (GU) |
|
| HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Urinary NOS | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Bronchopulmonary NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMORRHAGE/BLEEDING:: Hemorrhage/Bleeding - Other (Specify, R. neck after picc line) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| HEMORRHAGE/BLEEDING:: Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION:: Febrile neutropenia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | (fever of unknown origin without clinically or microbiologically documented infection)(ANC <1.0 x 10e9/L, fever >=38.5 degrees C) |
|
| INFECTION:: Infection(documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Abdomen NOS |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Bladder (urinary) |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Blood |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Brain (encephalitis, infectious) |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Catheter-related |
|
| INFECTION:Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Cecum |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Colon |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Conjunctiva |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Lung (pneumonia) |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Mucosa |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Spleen |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (Absolute neutrophil count (ANC) <1.0 x 10e9/L):: Urinary tract NOS |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Vein |
|
| INFECTION:: Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | (ANC <1.0 x 10e9/L):: Wound |
|
| INFECTION:: Infection - Other (Specify, BLOOD) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Oral cavity-gums (gingivitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Skin (cellulitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Not otherwise specified (NOS) |
|
| INFECTION:: Infection with unknown ANC:: Blood | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION:: Infection with unknown ANC:: Oral cavity-gums (gingivitis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| INFECTION:: Infection with unknown ANC:: Urinary tract NOS | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| LYMPHATICS:: Edema: head and neck | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| LYMPHATICS:: Edema: limb | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| LYMPHATICS:: Edema: trunk/genital | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | alanine aminotransferase (ALT), serum glutamic pyruvic transaminase (SGPT) |
|
| METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | aspartate aminotransferase (AST), serum glutamic oxaloacetic transaminase (SGOT) |
|
| METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Amylase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Creatinine | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Sodium, serum-high (hypernatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia) | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| MUSCULOSKELETAL/SOFT TISSUE:: Arthritis (non-septic) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| MUSCULOSKELETAL/SOFT TISSUE:: Joint-effusion | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| MUSCULOSKELETAL/SOFT TISSUE:: Muscle weakness, generalized or specific area (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Extremity-lower |
|
| MUSCULOSKELETAL/SOFT TISSUE:: Muscle weakness, generalized or specific area (not due to neuropathy) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Whole body/generalized |
|
| MUSCULOSKELETAL/SOFT TISSUE:: Musculoskeletal/Soft Tissue - Other (Specify, __) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | cervical spine range of motion |
|
| MUSCULOSKELETAL/SOFT TISSUE:: Soft tissue necrosis:: Extremity-lower | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Laryngeal nerve dysfunction | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Mood alteration:: Agitation | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Mood alteration:: Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Mood alteration:: Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Neuropathy: motor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Neuropathy: sensory | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Somnolence/depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Syncope (fainting) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| NEUROLOGY:: Tremor | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| OCULAR/VISUAL:: Ocular/Visual - Other (Specify, red eyes) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| OCULAR/VISUAL:: Ophthalmoplegia/diplopia (double vision) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| OCULAR/VISUAL:: Vision-blurred vision | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| OCULAR/VISUAL:: Vision-photophobia | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| OCULAR/VISUAL:: Watery eye (epiphora, tearing) | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain - Other (Specify, L wrist) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Abdomen Not otherwise specified (NOS) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Back | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Bladder | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Bone | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Buttock | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Chest/thorax NOS | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Dental/teeth/peridontal | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Extremity-limb | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Eye | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Head/headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Joint | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Muscle | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Neck | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Rectum | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain:: Throat/pharynx/larynx | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY:: Bronchospasm, wheezing | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY:: Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY:: Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY:: Nasal cavity/paranasal sinus reactions | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY:: Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY:: Pneumonitis/pulmonary infiltrates | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| RENAL/GENITOURINARY:: Cystitis | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| RENAL/GENITOURINARY:: Incontinence, urinary | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| RENAL/GENITOURINARY:: Obstruction, GU:: Ureter | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Genitourinary (GU) |
|
| RENAL/GENITOURINARY:: Urinary frequency/urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| VASCULAR:: Phlebitis (including superficial thrombosis) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| VASCULAR:: Thrombosis/embolism (vascular access-related) | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| VASCULAR:: Thrombosis/thrombus/embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| GASTROINTESTINAL:: Gastrointestinal - Other (Specify, tongue-blue spot) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| OCULAR/VISUAL:: Ocular/Visual - Other (Specify, dilated, non-reactive R.pupil | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain - Other (Specify, lumbar puncture (LP) site) | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain - Other (Specify, Pain L big toe | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain - Other (Specify, Pain: jaw pain) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain - Other (Specify, Pain:teeth) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain - Other (Specify, Pain: tooth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| PAIN:: Pain - Other (Specify, Pain:groin) | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
| Progressive Disease |
|
| Stable Disease |
|
| Not Evaluable |
|