Hodgkin Lymphoma
Conditions
Keywords
Hodgkin Lymphoma
Brief summary
This phase II trial is studying how well combination chemotherapy with or without radiation therapy works in treating young patients with favorable-risk Hodgkin lymphoma. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, mechlorethamine hydrochloride, vincristine sulfate, bleomycin, etoposide, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Radiation therapy uses high-energy x-rays to kill cancer cells for those patients that still had residual cancer at the end of chemotherapy. Giving combination chemotherapy with radiation therapy may kill more cancer cells and allow doctors to save the part of the body where the cancer started.
Detailed description
Patients receive doxorubicin hydrochloride intravenously (IV) and vinblastine IV on day 1 of weeks 1, 3, 5, and 7; mechlorethamine hydrochloride IV on day 1 of weeks 1 and 5; vincristine sulfate IV and bleomycin IV on day 1 of weeks 2, 4, 6, and 8; etoposide IV on day 1 of weeks 3 and 7; and prednisone orally (PO) three times daily every other day for 8 weeks. Two to 3 weeks after all chemotherapy is given, patients not achieving a complete response undergo radiation therapy to individual nodal sites (tailored fields). PRIMARY OBJECTIVES: 1\. To increase the complete response rate of favorable risk patients (excluding all patients with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at least 20% compared to favorable risk patients on HOD 99 after 8 weeks vincristine, doxorubicin hydrochloride, methotrexate and prednisone (VAMP). SECONDARY OBJECTIVES: 1. To estimate the disease failure rate within the radiation fields. 2. To examine patterns of treatment failure for children treated with low dose tailored field radiation therapy. 3. To describe acute hematologic and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia, and hospitalizations, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. 4. To compare the survival distributions (event-free and overall) and cumulative incidence of local failure and toxicities of favorable risk patients treated with 8 weeks of Stanford V chemotherapy and low-dose tailored-field radiation to those on the favorable risk group of the HOD 99 study that received VAMP and low-dose involved-field radiation. 5. To compare the survival distributions between patients that will not be prescribed radiotherapy after 8 weeks Stanford V and those patients on HOD 99 that did not receive radiotherapy after VAMP. 6. To estimate the event-free survival distributions of favorable risk patients treated with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy plus low dose tailored field radiation.
Interventions
The Stanford V regimen is an abbreviated, multi-agent, dose-intensive regimen that utilizes many of the most active chemotherapy agents for Hodgkin lymphoma: Vinblastine, Doxorubicin, Vincristine, Bleomycin, Mechlorethamine, Etoposide, and Prednisone
Patients who achieve less than a complete response after 8 weeks of chemotherapy will receive 25.5 Gy to individual nodal sites (tailored fields) starting 2-3 weeks following completion of all chemotherapy and recovery of ANC to at least 1000.
Sponsors
Study design
Eligibility
Inclusion criteria
* Histologically confirmed, previously untreated Hodgkin lymphoma. * Age: Participants must be 21 years of age or younger * Stage must be classified as one of the following: Ann Arbor stage IA or IIA with: * Non-bulky mediastinal disease (\< 33% mediastinal to thoracic ratio on CXR) * \< 3 nodal regions involved on the same side of the diaphragm * No "E" lesion * Female patients who are post-menarchal must have a negative pregnancy test. Patients of reproductive potential must agree to use an effective contraceptive method. * Signed informed consent * If re-evaluation of a patient's disease shows intermediate risk features, the patient will be removed from the HOD08.
Exclusion criteria
* Intermediate or High risk disease, defined as Stage IB, any III or IV or IA/IIA with "E" lesion(s), 3 or more nodal sites involved, or bulky mediastinal adenopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Response Rate Estimate | 8 weeks | To increase the complete response rate of favorable risk patients (excluding all patients with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at least 20% compared to favorable risk patients on HOD 99 after 8 weeks VAMP (NCT number: NCT00145600) .Complete response definition: Disappearance of all measurable or evaluable disease, signs, symptoms and biochemical changes related to the tumor. Biopsy confirmation is not mandatory. Residual PET-negative CT scan abnormalities representing \> 75% reduction (as measured by the product of 2 perpendicular diameters of lesions by CT or MR imaging) in the original tumor volume will be considered scar tissue without active tumor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Hematologic Toxicities | 6 months | Description of acute hematologic toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The acute hematologic toxicities were summarized descriptively. |
| Acute Infectious Toxicities | 6 months | Description of acute infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The acute infectious toxicities were summarized descriptively. |
| Disease Failure Rate Within Radiation Fields | median 2 year post therapy | Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks). |
| Treatment Failure Patterns for Children Treated With Tailored-field Radiation | median 2 years post therapy | Descriptive statistics related to local/distant failure will be produced. The cumulative incidence of local failure will be estimated and effects of prognostic factors will be examined. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Relapse rate within the radiation fields will be estimated and confidence interval will also be calculated. |
| Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Age | median 2 years post therapy | Age was examined for the association with cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with Wald test will be used to compute the p value for the statistical significance. |
| Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Gender | median 2 years post therapy | Gender was examined for the association with cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with Wald test will be used to compute the p value for the statistical significance. |
| Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Stage | median 2 years post therapy | Stage was examined for the association with cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with Wald test will be used to compute the p value for the statistical significance. |
| Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Histology | median 2 years post therapy | Histology was examined for its association with the cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with the Wald test will be used to compute the p-value for statistical significance. |
| Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99 | median 2 years post therapy | Log-rank tests are used to compare event-free survival and overall survival. Event-free survival is defined as time interval from the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Survival is defined as time interval from study enrollment to date of death from any cause or to date of last follow-up. Gray's test used to compare cumulative incidence of local failure between favorable risk patients treated on this protocol vs. treated on HOD99 and other regimens. |
| Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | median 2 years post therapy | Comparison of the toxicities with grade \> 2 of low-risk patients treated with reduced duration Stanford V chemotherapy with or without low-dose tailored-field radiation (current HOD08 protocol) to those of favorable-risk patients on HOD99 (NCT00145600). Grading of toxicities for HOD08 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. |
| Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy | median 2 years post therapy | Log-rank tests are used to compare event-free survival and overall survival. Event-free survival is defined as time interval from the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Survival is defined as time interval from study enrollment to date of death from any cause or to date of last follow-up. Gray's test used to compare cumulative incidence of local failure between favorable risk patients treated on this protocol vs. treated on HOD99 and other regimens. Patients who will not be prescribed Radiotherapy in both protocols are those who achieved CR on the response assessment after chemotherapy. |
| Event-free Survival Distributions of Favorable Risk Patients Treated With Stanford V Chemotherapy Alone and Patients Treated With Stanford V Chemotherapy Plus Low Dose Tailored-field Radiation | median 2 years post therapy | Event-free survival distributions of favorable risk patients treated with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy plus low dose tailored field radiation will be estimated by the Kaplan-Meier method. |
Countries
United States
Contacts
St. Jude Children's Research Hospital
Participant flow
Recruitment details
88 participants were enrolled from 5 institutions between June 2009 and October 2018.
Pre-assignment details
Two out of 88 enrolled patients are ineligible and were removed from the study. They were determined to be intermediate risk rather than low risk. One was taken off study after being re-consented on an expired consent and treated with cyclophosphamide instead of mechlorethamine; 1 patient withdrew from study but was evaluable for primary objective.
Participants by arm
| Arm | Count |
|---|---|
| Stanford V Chemotherapy Ann Arbor stage IA or IIA with:
1. Non-bulky mediastinal disease (\<33% mediastinal to thoracic ratio on chest x-ray)
2. \< 3 nodal regions involved on the same side of the diaphragm
3. No extranodal extension of disease | 85 |
| Total | 85 |
Baseline characteristics
| Characteristic | Stanford V Chemotherapy |
|---|---|
| Age, Continuous | 13.6 years STANDARD_DEVIATION 4.5 |
| Race/Ethnicity, Customized Race American Ind / Alaskan / White | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 3 Participants |
| Race/Ethnicity, Customized Race Asian and White | 1 Participants |
| Race/Ethnicity, Customized Race Black | 8 Participants |
| Race/Ethnicity, Customized Race Multiple Race (NOS) | 3 Participants |
| Race/Ethnicity, Customized Race Other | 3 Participants |
| Race/Ethnicity, Customized Race White | 66 Participants |
| Region of Enrollment United States Dana Farber Cancer Institute | 13 Participants |
| Region of Enrollment United States Maine Medical Center | 5 Participants |
| Region of Enrollment United States Rady Children's Hospital San Diego | 6 Participants |
| Region of Enrollment United States Stanford University Medical Center | 15 Participants |
| Region of Enrollment United States St. Jude Children's Research Hospital | 46 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 52 Participants |
| Stage: IA, IIA IA | 29 Participants |
| Stage: IA, IIA IIA | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 85 |
| other Total, other adverse events | 58 / 85 |
| serious Total, serious adverse events | 1 / 85 |
Outcome results
Complete Response Rate Estimate
To increase the complete response rate of favorable risk patients (excluding all patients with stage IA nodular lymphocyte predominant Hodgkin lymphoma) after 8 weeks Stanford V by at least 20% compared to favorable risk patients on HOD 99 after 8 weeks VAMP (NCT number: NCT00145600) .Complete response definition: Disappearance of all measurable or evaluable disease, signs, symptoms and biochemical changes related to the tumor. Biopsy confirmation is not mandatory. Residual PET-negative CT scan abnormalities representing \> 75% reduction (as measured by the product of 2 perpendicular diameters of lesions by CT or MR imaging) in the original tumor volume will be considered scar tissue without active tumor.
Time frame: 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stanford V Chemotherapy | Complete Response Rate Estimate | 77 percentage of participants |
Acute Hematologic Toxicities
Description of acute hematologic toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The acute hematologic toxicities were summarized descriptively.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stanford V Chemotherapy | Acute Hematologic Toxicities | Hemoglobin | 14 adverse events |
| Stanford V Chemotherapy | Acute Hematologic Toxicities | Neutrophils/granulocytes (ANC/AGC) | 64 adverse events |
| Stanford V Chemotherapy | Acute Hematologic Toxicities | Leukocytes (total WBC) | 74 adverse events |
| Stanford V Chemotherapy | Acute Hematologic Toxicities | Lymphopenia | 54 adverse events |
| Stanford V Chemotherapy | Acute Hematologic Toxicities | Platelets | 1 adverse events |
Acute Infectious Toxicities
Description of acute infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. The acute infectious toxicities were summarized descriptively.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stanford V Chemotherapy | Acute Infectious Toxicities | Febrile neutropenia | 8 Adverse events |
| Stanford V Chemotherapy | Acute Infectious Toxicities | Infection, Blood | 2 Adverse events |
| Stanford V Chemotherapy | Acute Infectious Toxicities | Infection, Upper Airway NOS | 1 Adverse events |
Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy
Log-rank tests are used to compare event-free survival and overall survival. Event-free survival is defined as time interval from the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Survival is defined as time interval from study enrollment to date of death from any cause or to date of last follow-up. Gray's test used to compare cumulative incidence of local failure between favorable risk patients treated on this protocol vs. treated on HOD99 and other regimens. Patients who will not be prescribed Radiotherapy in both protocols are those who achieved CR on the response assessment after chemotherapy.
Time frame: median 2 years post therapy
Population: HOD08 - CR: Participants who achieved CR after chemotherapy and were not prescribed RT. Two patients without RT were excluded: 1 was prescribed but did not receive it due to consent withdrawal, and 1 withdrew with no response results.~HOD99 - CR: Favorable Risk participants from NCT00145600 (HOD99) who achieved CR after chemotherapy and were not prescribed RT. Two patients prescribed RT but not receiving it were excluded: 1 due to progressive disease and 1 due to consent withdrawal.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stanford V Chemotherapy | Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy | 2-year Event-free Survival (EFS) Probability | 0.938 probability |
| Stanford V Chemotherapy | Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy | 2-year Overall Survival (OS) Probability | 1.000 probability |
| Stanford V Chemotherapy | Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy | 2-year Cumulative Incidence (CI) of Local Failure | 0.062 probability |
| HOD99 Participants | Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy | 2-year Event-free Survival (EFS) Probability | 0.894 probability |
| HOD99 Participants | Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy | 2-year Overall Survival (OS) Probability | 1.000 probability |
| HOD99 Participants | Comparison of Event-free and Overall Survival Distributions and Cumulative Incidence of Local Failure Between Patients That Will Not be Prescribed Radiotherapy After 8 Weeks Stanford V and Those Patients on HOD99 That Received VAMP Without Radiotherapy | 2-year Cumulative Incidence (CI) of Local Failure | 0.106 probability |
Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99
Log-rank tests are used to compare event-free survival and overall survival. Event-free survival is defined as time interval from the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Survival is defined as time interval from study enrollment to date of death from any cause or to date of last follow-up. Gray's test used to compare cumulative incidence of local failure between favorable risk patients treated on this protocol vs. treated on HOD99 and other regimens.
Time frame: median 2 years post therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stanford V Chemotherapy | Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99 | 2-year Event-free Survival (EFS) Probability | 0.939 probability |
| Stanford V Chemotherapy | Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99 | 2-year Overall Survival (OS) Probability | 1.000 probability |
| Stanford V Chemotherapy | Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99 | 2-year Cumulative Incidence (CI) of Local Failure | 0.061 probability |
| HOD99 Participants | Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99 | 2-year Event-free Survival (EFS) Probability | 0.909 probability |
| HOD99 Participants | Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99 | 2-year Overall Survival (OS) Probability | 1.000 probability |
| HOD99 Participants | Comparison of Event-free and Overall Survival Distributions, and Cumulative Incidence of Local Failure of Patients Treated on This Study to Outcome in the Favorable Risk Group of HOD99 | 2-year Cumulative Incidence (CI) of Local Failure | 0.068 probability |
Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99
Comparison of the toxicities with grade \> 2 of low-risk patients treated with reduced duration Stanford V chemotherapy with or without low-dose tailored-field radiation (current HOD08 protocol) to those of favorable-risk patients on HOD99 (NCT00145600). Grading of toxicities for HOD08 and HOD99 used the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
Time frame: median 2 years post therapy
Population: Additional description can be found here for the following Row Titles:~Febrile neutropenia - (fever of unknown origin without clinically or microbiologically documented infection)(ANC \<1.0 x 10e9/L, fever \>=38.5 degrees C)~Infection, Blood - (documented clinically or microbiologically documented infection) (ANC\<1.0x10\^9/L, fever \> 38.5C)~Infection, Paranasal - (documented clinically or microbiologically) with Grade 3 or 4 neutrophils (ANC \<1.0 x 10e9/L)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Neuralgia/peripheral nerve | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Calcium, serum-low (hypocalcemia) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Bone | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Renal failure | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Flu-like syndrome | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Paranasal | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Blood | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Personality/behavioral | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Gastritis (including bile reflux gastritis) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neutrophils/granulocytes (ANC/AGC) | 32 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypoxia | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-low (hypokalemia) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Glucose, serum-high (hyperglycemia) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Mood alteration, Depression | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Bicarbonate, serum-low | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypotension | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/thrombus/embolism | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-high (hyperkalemia) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hemoglobin | 6 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Chest/thorax NOS | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Extremity-limb | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain - Other (Specify, __) | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Nausea | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Leukocytes (total WBC) | 34 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Blood/Bone Marrow - Other (Specify, __) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Obstruction, GU, Bladder | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neuropathy: sensory | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Constipation | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-high (hypermagnesemia) | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Pharynx | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Lymphopenia | 23 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/embolism (vascular access-related) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Dehydration | 1 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Insomnia | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Joint | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Weight gain | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Abdomen NOS | 2 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Febrile neutropenia | 4 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with unknown ANC, Lung (pneumonia) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Vomiting | 2 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Sodium, serum-low (hyponatremia) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Blood | 2 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | 0 adverse events |
| Stanford V Chemotherapy | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-low (hypomagnesemia) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neutrophils/granulocytes (ANC/AGC) | 25 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Lymphopenia | 10 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Calcium, serum-low (hypocalcemia) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Obstruction, GU, Bladder | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-high (hypermagnesemia) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-low (hypomagnesemia) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Mood alteration, Depression | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neuropathy: sensory | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Nausea | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/embolism (vascular access-related) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Constipation | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Weight gain | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Dehydration | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Sodium, serum-low (hyponatremia) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Febrile neutropenia | 2 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Renal failure | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Flu-like syndrome | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-low (hypokalemia) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Gastritis (including bile reflux gastritis) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Glucose, serum-high (hyperglycemia) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-high (hyperkalemia) | 1 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hemoglobin | 2 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Vomiting | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypotension | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypoxia | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Bicarbonate, serum-low | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Personality/behavioral | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Blood | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Neuralgia/peripheral nerve | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Paranasal | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Blood | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Joint | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Extremity-limb | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Pharynx | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Blood/Bone Marrow - Other (Specify, __) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Chest/thorax NOS | 1 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Bone | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with unknown ANC, Lung (pneumonia) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/thrombus/embolism | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Abdomen NOS | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Insomnia | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain - Other (Specify, __) | 0 adverse events |
| HOD99 Participants | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Leukocytes (total WBC) | 18 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Joint | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Renal failure | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Blood | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Febrile neutropenia | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-low (hypomagnesemia) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Dehydration | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Sodium, serum-low (hyponatremia) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Abdomen NOS | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/thrombus/embolism | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Extremity-limb | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Constipation | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Insomnia | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Pharynx | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Nausea | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neuropathy: sensory | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Chest/thorax NOS | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/embolism (vascular access-related) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with unknown ANC, Lung (pneumonia) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Lymphopenia | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain - Other (Specify, __) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hemoglobin | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Mood alteration, Depression | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Leukocytes (total WBC) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Vomiting | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Calcium, serum-low (hypocalcemia) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypotension | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Glucose, serum-high (hyperglycemia) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-high (hyperkalemia) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Personality/behavioral | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Gastritis (including bile reflux gastritis) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypoxia | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Blood/Bone Marrow - Other (Specify, __) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Bone | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-low (hypokalemia) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-high (hypermagnesemia) | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Blood | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Bicarbonate, serum-low | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Neuralgia/peripheral nerve | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Weight gain | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Flu-like syndrome | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Obstruction, GU, Bladder | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Paranasal | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS | 0 adverse events |
| HOD08 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-low (hypokalemia) | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | ALT, SGPT (serum glutamic pyruvic transaminase) | 2 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | AST, SGOT(serum glutamic oxaloacetic transaminase) | 2 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Bicarbonate, serum-low | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Blood/Bone Marrow - Other (Specify, __) | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Calcium, serum-low (hypocalcemia) | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Constipation | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Dehydration | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Febrile neutropenia | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | 2 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Flu-like syndrome | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Gastritis (including bile reflux gastritis) | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Glucose, serum-high (hyperglycemia) | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hemoglobin | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypotension | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypoxia | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Blood | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Paranasal | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Blood | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Pharynx | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis) | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with unknown ANC, Lung (pneumonia) | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Insomnia | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Leukocytes (total WBC) | 23 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Lymphopenia | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-high (hypermagnesemia) | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-low (hypomagnesemia) | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Mood alteration, Depression | 3 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Nausea | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neuropathy: sensory | 4 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neutrophils/granulocytes (ANC/AGC) | 36 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Obstruction, GU, Bladder | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain - Other (Specify, __) | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Abdomen NOS | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Bone | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Chest/thorax NOS | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Extremity-limb | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Joint | 2 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Neuralgia/peripheral nerve | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Personality/behavioral | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-high (hyperkalemia) | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Renal failure | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Sodium, serum-low (hyponatremia) | 0 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/embolism (vascular access-related) | 2 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/thrombus/embolism | 1 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Vomiting | 3 adverse events |
| HOD99 - Grade 3 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Weight gain | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Pharynx | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Insomnia | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain - Other (Specify, __) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with unknown ANC, Lung (pneumonia) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Abdomen NOS | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/thrombus/embolism | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Bone | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Chest/thorax NOS | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Leukocytes (total WBC) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Bicarbonate, serum-low | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Extremity-limb | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Blood | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Joint | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Paranasal | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Blood | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Neuralgia/peripheral nerve | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypoxia | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Weight gain | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Personality/behavioral | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypotension | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hemoglobin | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Vomiting | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Phosphate, serum-low (hypophosphatemia) | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Glucose, serum-high (hyperglycemia) | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-high (hyperkalemia) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Gastritis (including bile reflux gastritis) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Flu-like syndrome | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-high (hypermagnesemia) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-low (hypokalemia) | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Renal failure | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Febrile neutropenia | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Dehydration | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Sodium, serum-low (hyponatremia) | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Constipation | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Calcium, serum-low (hypocalcemia) | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/embolism (vascular access-related) | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Nausea | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Mood alteration, Depression | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neuropathy: sensory | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-low (hypomagnesemia) | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neutrophils/granulocytes (ANC/AGC) | 51 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Lymphopenia | 0 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Blood/Bone Marrow - Other (Specify, __) | 1 adverse events |
| HOD99 - Grade 4 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Obstruction, GU, Bladder | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Sodium, serum-low (hyponatremia) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Insomnia | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Obstruction, GU, Bladder | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Bicarbonate, serum-low | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Phosphate, serum-low (hypophosphatemia) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain - Other (Specify, __) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with unknown ANC, Lung (pneumonia) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Glucose, serum-high (hyperglycemia) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Urinary tract NOS | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Weight gain | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Calcium, serum-low (hypocalcemia) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Abdomen NOS | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Gastritis (including bile reflux gastritis) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Upper airway NOS | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Vomiting | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-high (hypermagnesemia) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-high (hyperkalemia) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Bone | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Skin (cellulitis) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Dehydration | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Pharynx | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/thrombus/embolism | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Flu-like syndrome | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Chest/thorax NOS | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Blood/Bone Marrow - Other (Specify, __) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Catheter-related | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Nausea | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Leukocytes (total WBC) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Potassium, serum-low (hypokalemia) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Extremity-limb | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection with normal ANC or Grade 1 or 2 neutrophils, Blood | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Paranasal | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | AST, SGOT(serum glutamic oxaloacetic transaminase) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Mood alteration, Depression | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Joint | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Febrile neutropenia | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Infection, Blood | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | ALT, SGPT (serum glutamic pyruvic transaminase) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neutrophils/granulocytes (ANC/AGC) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Renal failure | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Pain, Neuralgia/peripheral nerve | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypoxia | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Thrombosis/embolism (vascular access-related) | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hypotension | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Lymphopenia | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Constipation | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Personality/behavioral | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Neuropathy: sensory | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Hemoglobin | 0 adverse events |
| HOD99 - Grade 5 | Comparison of Toxicities of Patients Treated on This Study to Outcome and Toxicities in the Favorable Risk Group of HOD99 | Magnesium, serum-low (hypomagnesemia) | 0 adverse events |
Disease Failure Rate Within Radiation Fields
Defined as disease that recurs in the initially involved nodal region within the field of irradiation. The disease failure rate within the radiation fields will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).
Time frame: median 2 year post therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stanford V Chemotherapy | Disease Failure Rate Within Radiation Fields | 0.059 probability that the event occurs |
Event-free Survival Distributions of Favorable Risk Patients Treated With Stanford V Chemotherapy Alone and Patients Treated With Stanford V Chemotherapy Plus Low Dose Tailored-field Radiation
Event-free survival distributions of favorable risk patients treated with Stanford V chemotherapy alone and patients treated with Stanford V chemotherapy plus low dose tailored field radiation will be estimated by the Kaplan-Meier method.
Time frame: median 2 years post therapy
Population: Stanford V Chemotherapy Alone: Out of the 68 patients treated with Stanford V chemotherapy alone, without low-dose tailored-field radiation:~66 patients were not prescribed radiotherapy as they achieved a Complete Response (CR) on the Response Assessment after chemotherapy.~One patient didn't achieve a CR but withdrew from the study before receiving radiotherapy.~One patient had a missing response result and withdrew from the study without undergoing radiotherapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stanford V Chemotherapy | Event-free Survival Distributions of Favorable Risk Patients Treated With Stanford V Chemotherapy Alone and Patients Treated With Stanford V Chemotherapy Plus Low Dose Tailored-field Radiation | 0.939 probability of event free survival |
| HOD99 Participants | Event-free Survival Distributions of Favorable Risk Patients Treated With Stanford V Chemotherapy Alone and Patients Treated With Stanford V Chemotherapy Plus Low Dose Tailored-field Radiation | 0.941 probability of event free survival |
Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Age
Age was examined for the association with cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with Wald test will be used to compute the p value for the statistical significance.
Time frame: median 2 years post therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stanford V Chemotherapy | Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Age | 0.969 hazard ratio |
Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Gender
Gender was examined for the association with cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with Wald test will be used to compute the p value for the statistical significance.
Time frame: median 2 years post therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stanford V Chemotherapy | Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Gender | 0.000 hazard ratio |
Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Histology
Histology was examined for its association with the cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with the Wald test will be used to compute the p-value for statistical significance.
Time frame: median 2 years post therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stanford V Chemotherapy | Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Histology | 34027.680 hazard ratio |
Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Stage
Stage was examined for the association with cumulative incidence of local failure. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Fine and Gray's competing risk regression model with Wald test will be used to compute the p value for the statistical significance.
Time frame: median 2 years post therapy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stanford V Chemotherapy | Prognostic Factors for Local Failure in Children Treated With Tailored-Field Radiation: Stage | 30101.410 hazard ratio |
Treatment Failure Patterns for Children Treated With Tailored-field Radiation
Descriptive statistics related to local/distant failure will be produced. The cumulative incidence of local failure will be estimated and effects of prognostic factors will be examined. Effect of competing risks (distant failure, second malignancy and death) will be taken into account. Relapse rate within the radiation fields will be estimated and confidence interval will also be calculated.
Time frame: median 2 years post therapy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stanford V Chemotherapy | Treatment Failure Patterns for Children Treated With Tailored-field Radiation | 2-year Cumulative incidence of distant failure | 0.000 probability that the event occurs |
| Stanford V Chemotherapy | Treatment Failure Patterns for Children Treated With Tailored-field Radiation | 2-year Cumulative incidence of local failure | 0.059 probability that the event occurs |