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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA033572 | U.S. NIH Grant/Contract | View source | |
| CHNMC-99041 | |||
| CDR0000564777 | Registry Identifier | NCI PDQ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant or a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving mycophenolate mofetil and cyclosporine before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects and best way to give busulfan together with etoposide and total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell or bone marrow transplant for advanced hematologic cancer.
OBJECTIVES:
OUTLINE:
After completion of study treatment, patients are followed annually for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Busulfan, FTBI and VP16 | Experimental | IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| busulfan | Drug |
| ||
| cyclosporine |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival at 5 Years Post-Transplant. | Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%. | Date of Transplant to Five Years post-Transplant |
| Disease-free Survival at Five Years Post-transplant | Kaplan-Meier estimate of an event of relapse or death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%. | Date of transplant to five years post-transplant |
| Overall Survival Comparing Diagnosis Groups | Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%. | Date of Transplant to Five Years post-Transplant |
| Cumulative Incidence of Relapse With Transplant-related Death as the Competing Risk: Diagnosis Groups Are Compared. | Fine and Gray estimate of cumulative incidence of Relapse, with Death as the competing risk. Estimate is at five years post-transplant. Ninety-five percent confidence interval is by logit transformation of Greenwood variance to keep the interval within the probability space of 0% to 100%. | Date of Transplant to Five Years post-Transplant. Estimate is at Five Years post-Transplant. |
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DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Acute myeloid leukemia (AML)
Acute lymphoblastic leukemia (ALL)
Blastic phase chronic myelogenous leukemia
Refractory anemia with excess blasts
Refractory anemia with excess blasts in transformation
HLA -A, -B, -C, -DR identical sibling donor match available
No relapse after prior bone marrow transplantation
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony S. Stein, MD | City of Hope Medical Center | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | Busulfan, Fractionated Total Body Irradiation (FTBI) + Etoposide (VP16) | IV Busulfan + 12 cGy Fractionated Total Body Irradiation (FTBI) + Etoposide (VP16) prior to allogeneic Bone Marrow Transplant busulfan cyclosporine etoposide mycophenolate mofetil allogeneic bone marrow transplantation allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Apr 20, 2004 |
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|
| etoposide | Drug |
|
| mycophenolate mofetil | Drug |
|
| allogeneic bone marrow transplantation | Procedure |
|
| allogeneic hematopoietic stem cell transplantation | Procedure |
|
| peripheral blood stem cell transplantation | Procedure |
|
| total-body irradiation | Radiation |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Enrolled on protocol after screening for eligiblility
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| ID | Title | Description |
|---|---|---|
| BG000 | Busulfan, FTBI and VP16 | IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant busulfan cyclosporine etoposide mycophenolate mofetil allogeneic bone marrow transplantation allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Patient Assessment of Mortality (PAM) Score | A risk score for mortality after allogeneic hematopoietic cell transplantation. Ann Intern Med 2006; 144(6):407-414. Parimon T, Au DH, Martin PH, Chien JW. "We generated 4 categories of PAM scores by setting cutoffs according to the probability of death. Scores ranged from 9 to 16 for category 1 (probability of death, < 25%), from 17 to 23 for category 2 (probability of death, 25% to 50%), from 24 to 30 for category 3 (probability of death, 50% to 75%), and from 31 to 44 for category 4 (probability of death, > 75%)." | Median | Full Range | units on a scale |
| ||||||||||||||||
| Disease Status at Transplant | Disease classification was based on WHO criteria [Vardiman, Blood 2002]: Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL), and untreated refractory anemia with excess blasts in transformation (RAEB-t). | Count of Participants | Participants |
| |||||||||||||||||
| Cytogenetics | Cytogenetics were based on Southwest Oncology Group criteria [Leith CP, Blood 1997; Pullarkat V, Blood 2008]. Intermediate: normal and all other cytogenetic abnormalities. Unfavorable: -5/5q-, -7/7q-, inv(3), 11q abn, 17p abn or i(17q), del(20q), dmins/hsrs, +13, t(9; 22), complex (>3 abn) karyotypes. Indeterminate: all other clonal cytogenetic abnormalities. | Count of Participants | Participants |
| |||||||||||||||||
| Stem Cell Source | Count of Participants | Participants |
| ||||||||||||||||||
| WBC pre-conditioning | Patients with active disease | Median | Full Range | x10^9 cells/L |
| ||||||||||||||||
| Percent Blasts in Bone Marrow | Patients with active disease | Median | Full Range | percent of leukocytes |
| ||||||||||||||||
| Percent Blasts in Peripheral Blood | Patients with Active Disease | Median | Full Range | percent of leukocytes |
|
| 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 | Overall Survival at 5 Years Post-Transplant. | Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%. | The Full Study Population | Posted | Number | 95% Confidence Interval | percentage of survival probability | Date of Transplant to Five Years post-Transplant |
|
|
| |||||||||||||||||||||||||
| Primary | Disease-free Survival at Five Years Post-transplant | Kaplan-Meier estimate of an event of relapse or death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%. | Posted | Number | 95% Confidence Interval | percentage of survival probability | Date of transplant to five years post-transplant |
|
| |||||||||||||||||||||||||||
| Primary | Overall Survival Comparing Diagnosis Groups | Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%. | Study cohort separated into four disease groups. | Posted | Number | 95% Confidence Interval | percentage of survival probability | Date of Transplant to Five Years post-Transplant |
| |||||||||||||||||||||||||||
| Primary | Cumulative Incidence of Relapse With Transplant-related Death as the Competing Risk: Diagnosis Groups Are Compared. | Fine and Gray estimate of cumulative incidence of Relapse, with Death as the competing risk. Estimate is at five years post-transplant. Ninety-five percent confidence interval is by logit transformation of Greenwood variance to keep the interval within the probability space of 0% to 100%. | Posted | Number | 95% Confidence Interval | percentage of relapse probability | Date of Transplant to Five Years post-Transplant. Estimate is at Five Years post-Transplant. |
|
From the start time of the study treatment up to Day 100 post-transplant
Systematic Assessment: See the time periods, above.
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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 | Busulfan, FTBI and VP16 | IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant busulfan cyclosporine etoposide mycophenolate mofetil allogeneic bone marrow transplantation allogeneic hematopoietic stem cell transplantation peripheral blood stem cell transplantation total-body irradiation | 18 | 30 | 2 | 30 | 30 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytes (total WBC) for BMT studies, if specified in the protocol. | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol. | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction/hypersensitivity (including drug fever) | Immune System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip) | Immune System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Allergy/Immunology - Other: DRY NOSE | Immune System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Allergy/Immunology - Other: ENGRAFTMENT SYNDROME | Immune System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Auditory/Ear - Other: DECREASED HEARING DUETO MEDS (AZITHROMYCIN) | Ear and Labyrinth Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Auditory/Ear - Other: PLUGGED EARS | Ear and Labyrinth Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Otitis, external ear (non-infectious) | Ear and Labyrinth Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Graft versus host disease | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Veno-Occlusive Disease (VOD) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Blood/Bone Marrow - Other (Specify, __) | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Bone marrow cellularity | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemoglobin | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemoglobin for leukemia studies or bone marrow infiltrative/ myelophthisic processes. | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemolysis (e.g., immune hemolytic anemia, drug-related hemolysis) | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Leukocytes (total WBC) | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Leukocytes (total WBC) for BMT studies, if specified in the protocol. | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Lymphopenia | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol. | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Platelets | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Platelets for BMT studies, if specified in the protocol. | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Transfusion: Platelets | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Transfusion: Platelets for BMT studies, if specified in the protocol. | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Transfusion: pRBCs | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Transfusion: pRBCs for BMT studies, if specified in the protocol. | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Acute graft versus host disease (GVHD) (COH) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Chronic graft versus host disease (GVHD) (COH) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Cardiac Arrhythmia - Other (Specify, __) | Cardiac Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Supraventricular and nodal arrhythmia | Cardiac Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Cardiac General - Other (Specify, __) | Cardiac Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Cardiac General - Other: CARDIOMEGALY | Cardiac Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hypertension | Cardiac Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hypotension | Cardiac Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Myocarditis | Cardiac Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Edema | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| INR (International Normalized Ratio of prothrombin time) | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| PTT (Partial Thromboplastin Time) | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Constitutional Symptoms - Other (Specify, __) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Insomnia | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Rigors/chills | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Sweating (diaphoresis) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Weight gain | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Weight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified in the protocol. | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Weight loss | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Bruising (in absence of Grade 3 or 4 thrombocytopenia) | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: ACTINIC PARAKERATIONS | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: BRUISE ON RIGHT ARM | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: BURNING SENSATION IN ARM PITS | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: CONTACT DERMATITIS | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: DIFFUSE ERYTHEMATOUS SCROTUM | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: EDEMA DUE TO BM BIOPSY | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: FACIAL PLETHORA | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: FACIAL SWELLING | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: INGROWN TOENAIL | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: INTRAVASCULAR MICROTHROMBI - LEFT THIGH | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: LEFT HIP ABRASION | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: LIP LESION | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: PALLOR | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: PAROTID SWELLING | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: PERI-RECTAL EXCORIATION | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: PERIANAL AREA SKIN IRRITATION | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: PERIRECTAL AREA SKIN IRRITATION | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: PERIRECTAL ULCER | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: RASH SECONDARY CHEMO | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: REDNESS ON SCROTUM | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: ROSACEA | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: SCROTAL RASH | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: SKIN/JAUNDICE | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: UP ORAL ULCER | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: VP-16 RASH | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dermatology/Skin - Other: VP-16 SKIN RASH | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dry skin | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Flushing | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hair loss/alopecia (scalp or body) | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Injection site reaction/extravasation changes | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Nail changes | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pigmentation changes (e.g., vitiligo) | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pruritus/itching | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Rash/dermatitis associated with high-dose chemotherapy or BMT studies. | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Rash/desquamation | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Rash/desquamation associated with graft versus host disease (GVHD). | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Rash: hand-foot skin reaction | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Urticaria (hives, welts, wheals) | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Wound complication, non-infectious | Skin and Subcutaneous Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae) | Endocrine Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Anorexia | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ascites (non-malignant) | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Colitis | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Constipation | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dehydration | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Diarrhea associated with graft versus host disease (GVHD) | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dry mouth/salivary gland (xerostomia) | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dysphagia-esophageal related to radiation | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Esophagitis | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastritis (including bile reflux gastritis) | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: ABDOMINAL BLOATING | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: ABDOMINAL BLOATNESS | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: ABDOMINAL CRAMPS | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: ABDOMINAL DISTENSION | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: CHOLECYSTITIS | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: DRY HEAVES | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: DRY MOUTH | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: EPIGASTRIC DISCOMFORT | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: ERYTHEMA STOMACH | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: ESOPHAGEAL DISCOMFORT | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: FREQUENT STOOLS (NOT DIARRHEA) | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: GAGGING | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: GERD | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: GURGLY STOMACH | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: INCREASED SALIVATION | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: ORAL THRUSH | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: RECTAL LESION | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: RED THROAT | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: RETCHING | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: SCRATCHY THROAT | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: SMALL POLYPS STOMACH | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: SWELLING OF CHECKS | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: UPPER GI/GVHD | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: WRECHING | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Gastrointestinal - Other: WRETCHING | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Heartburn/dyspepsia | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ileus, GI (functional obstruction of bowel, i.e., neuroconstipation) | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Mucositis/stomatitis (functional/symptomatic) | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Nausea | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Salivary gland changes/saliva | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in the protocol. | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Taste alteration (dysgeusia) | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hematemesis | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hematuria (in the absence of vaginal bleeding) | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemoptysis | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Melena/GI bleeding | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Rectal bleeding/hematochezia | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage, GU | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage, pulmonary/upper respiratory | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other: BLEEDING FROM PENIS MEATUS | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other: BLEEDING FROM SCRATCH | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other: BLOOD IN SPUTUM | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other: BLOOD TINGLED MUCUS | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other: HEMORRHOIDS | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other: SPUTUM WITH BLOODSTREAM | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other: SUBCONJUNCTIVAL HEMORRHAGE | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other: TELANGIECTASIA CHEST | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hemorrhage/Bleeding - Other: TONGUE BLEEDING | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Bilirubin associated with graft versus host disease (GVHD). | Hepatobiliary Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hepatic enlargement | Hepatobiliary Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hepatobiliary/Pancreas - Other: JAUNDICE | Hepatobiliary Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Febrile neutropenia (fever of unknown origin) | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Infection - Other (Specify, __) | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Infection - Other: ORAL CANDIDIASIS | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Infection - Other: UPPER RESPIRATORY INFECTION | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Infection with unknown ANC | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Infection (documented) with grade 3 or 4 neutropenia | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Infection with unknown ANC | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Infection without neutropenia | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Infection, Bacterial (COH) | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Infection, Fungal (COH) | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Infection, Viral | Infections and Infestations | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Lymphatics - Other: LYMPHADENOPATHY | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Lymphatics CERVICAL LYMPHOADENOPATHY | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Lymphatics MILD LYMPHEDEMIA (NECK) | Blood and Lymphatic System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| ALT, SGPT (serum glutamic pyruvic transaminase) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| AST, SGOT(serum glutamic oxaloacetic transaminase) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Acidosis (metabolic or respiratory) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Albumin, serum-low (hypoalbuminemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Alkaline phosphatase | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Alkalosis (metabolic or respiratory) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Bicarbonate, serum-low | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Bilirubin (hyperbilirubinemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Calcium, serum-high (hypercalcemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Calcium, serum-low (hypocalcemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Cholesterol, serum-high (hypercholesteremia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Creatinine | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| GGT (gamma-Glutamyl transpeptidase) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Glucose, serum-high (hyperglycemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Glucose, serum-low (hypoglycemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Magnesium, serum-high (hypermagnesemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Magnesium, serum-low (hypomagnesemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Phosphate, serum-low (hypophosphatemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Potassium, serum-high (hyperkalemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Potassium, serum-low (hypokalemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Sodium, serum-high (hypernatremia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Sodium, serum-low (hyponatremia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Triglyceride, serum-high (hypertriglyceridemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Uric acid, serum-high (hyperuricemia) | Metabolism and Nutrition Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Muscle weakness, generalized or specific area (not due to neuropathy) | Musculoskeletal and Connective Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other: DEGERATIVE CHANGES IN ANTERIOR THORACIC SPINE | Musculoskeletal and Connective Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other: HAND CRAMPS | Musculoskeletal and Connective Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other: MUSCLE CRAMPS | Musculoskeletal and Connective Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other: MUSCLE CRAMPS-FINGERS | Musculoskeletal and Connective Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other: MUSCLE SPANAM | Musculoskeletal and Connective Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other: MUSCLE SPASM | Musculoskeletal and Connective Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Musculoskeletal/Soft Tissue - Other: NUMBNESS, TINGLING | Musculoskeletal and Connective Tissue Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ataxia (incoordination) | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Confusion | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dizziness | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hallucinations | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Mood alteration | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Neurology - Other: ADJUSTMENT DISORDER WITH MIXED ANXIETY AND DEPRESSION | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Neurology - Other: METABOLIC ENCEPHALOPATHY | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Neurology - Other: NIGHTMARES | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Neurology - Other: PANIC ATTACK | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Neuropathy: motor | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Neuropathy: sensory | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Personality/behavioral | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Psychosis (hallucinations/delusions) | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pyramidal tract dysfunction (increased tone, hyperreflexia, pos Babinski, decreased motor coord | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Somnolence/depressed level of consciousness | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Syncope (fainting) | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Tremor | Nervous System Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dry eye syndrome | Eye Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ocular surface disease | Eye Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ocular/Visual - Other: CHEMON'S--SCLERAL EDEMA | Eye Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ocular/Visual - Other: ICTERIC SCLERAE | Eye Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ocular/Visual - Other: JAUNDICED SCLERAL | Eye Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ocular/Visual - Other: RED EYES | Eye Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ocular/Visual - Other: REDNESS (NOT DRY) | Eye Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Ocular/Visual - Other: YELLOW DISCHARGE FROM THE EYES | Eye Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Vision-blurred vision | Eye Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: ARM PIT PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: BACK PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: BODY ACHE | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: CATHETER PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: CRAMPING (ABDOMINAL) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: DRY HEAVES | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: EAR PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: EPIGASTRIC PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: GENERALIZED BODY PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: HANDS PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: HICKMAN CATHETER PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: HICKMAN SITE PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: HIP PAIN (DUE TO BIOPSY) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: INGROWN TOENAIL PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: KNEE PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: LEG PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: LOW BACK PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: MOUTH PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: NECK PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: PAIN AT RAC SITE | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: PAIN FROM BM BIOPSY SITE | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: PAIN IN MANDIBLE | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: PAIN SYNDROME DUE TO MUCOSITIS | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: PAIN TO LYMPH NODE | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: PAROTID PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: PERIRECTAL PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: R. ARM PAIN FROM THE FALL | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: RAC SITE PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: RIB PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: SCROTAL PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: SHOULDER PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: SKIN PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: SUBMANDIBULAR TENDERNESS | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: TENDER PAROTID GLANDS | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: THIGH PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: THROAT PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: THROAT PAIN (POSSIBLE URI) | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: TONGUE PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain - Other: TWINGES FEET | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pain RECTAL PAIN | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Adult Respiratory Distress Syndrome (ARDS) | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Cough | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hiccoughs (hiccups, singultus) | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Hypoxia | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pneumonitis/pulmonary infiltrates | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: BRONCHOSPASM | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: DECREASED BREATH SOUND AT LUNG BASES | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: EXCORIATION OF POSTERIOR | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: MILD ELEVATION OF RIGHT HEMIDIAPHRAGM | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: NASAL CONGESTION | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: NASAL STUFFINESS | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: NASAL/SINUS CONGESTION | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: PULMONARY VASCULAR CONGESTION | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: RESPIRATORY DISTRESS | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: RUNNING NOSE | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: SINUS CONGESTION/RUNNY NOSE | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: SINUS/NOSE CONGESTION | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: TACHYPNEA | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: UPPER AIRWAY OBSTRUCTION | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Pulmonary/Upper Respiratory - Other: URI | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) | Respiratory, Thoracic and Mediastinal Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Bladder spasms | Renal and Urinary Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Incontinence | Renal and Urinary Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Renal/Genitourinary - Other (Specify, __) | Renal and Urinary Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Renal/Genitourinary - Other: VAG. DISCHARGE | Renal and Urinary Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Urinary frequency/urgency | Renal and Urinary Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Urinary retention (including neurogenic bladder) | Renal and Urinary Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Libido | Reproductive System and Breast Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Vaginitis (not due to infection) | Reproductive System and Breast Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Syndromes - Other: RASH GVHD | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Tumor lysis syndrome | General Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
| |
| Thrombosis/thrombus/embolism | Vascular Disorders | CTC v2.0 4/30/1999 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Stein, MD, Clinical Professor | Department of Hematology, City of Hope | 626-537-5748 | astein@coh.org |
| Aug 23, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009190 | Myelodysplastic Syndromes |
| D000013 | Congenital Abnormalities |
| D015470 | Leukemia, Myeloid, Acute |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D001752 | Blast Crisis |
| D000754 | Anemia, Refractory, with Excess of Blasts |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007951 | Leukemia, Myeloid |
| D007945 | Leukemia, Lymphoid |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015464 | Leukemia, Myelogenous, Chronic, BCR-ABL Positive |
| D002471 | Cell Transformation, Neoplastic |
| D063646 | Carcinogenesis |
| D009385 | Neoplastic Processes |
| D009196 | Myeloproliferative Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000753 | Anemia, Refractory |
| D000740 | Anemia |
Not provided
Not provided
| ID | Term |
|---|---|
| D002066 | Busulfan |
| D016572 | Cyclosporine |
| D005047 | Etoposide |
| D009173 | Mycophenolic Acid |
| D036102 | Peripheral Blood Stem Cell Transplantation |
| D014916 | Whole-Body Irradiation |
| ID | Term |
|---|---|
| D002072 | Butylene Glycols |
| D006018 | Glycols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D008698 | Mesylates |
| D000476 | Alkanesulfonates |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D018380 | Hematopoietic Stem Cell Transplantation |
| D033581 | Stem Cell Transplantation |
| D017690 | Cell Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| D008919 | Investigative Techniques |
Not provided
Not provided
|
| White, Not Hispanic |
|
|
| AML in First Relapse |
|
|
| AML in Induction Failure |
|
|
| untreated RAEB-t |
|
|
| ALL in First Relapse |
|
|
| ALL in Second Relapse |
|
|
| ALL in Induction Failure |
|
|
| Intermediate |
|
|
| Unfavorable |
|
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
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|