S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer

Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node-Negative Breast Cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00070564

Enrollment

3294

Registered

2003-10-07

Start date

2003-11-01

Completion date

2027-01-01

Last updated

2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage II breast cancer, stage IA breast cancer, stage IB breast cancer, stage IIIC breast cancer, male breast cancer, HER2-positive breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer

Brief summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer. PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.

Detailed description

OBJECTIVES: * Compare the disease-free survival of patients with node-positive or high-risk node-negative breast cancer treated with 2 different schedules of adjuvant doxorubicin, cyclophosphamide, and paclitaxel. * Compare the overall survival of patients treated with these regimens. * Compare the toxic effects of these regimens in these patients. * Correlate outcome with putative prognostic markers in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms (arms V and VI) (arms I-IV closed 11/10/10). * Arm I: (closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. * Arm II: (closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I. * Arm III: (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses. * Arm IV: (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III. * Arm V: Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. * Arm VI: Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim as in arm V. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses. In all arms, treatment continues in the absence of disease progression or unacceptable toxicity. In all arms patients with HER2/neu-positive tumors also receive trastuzumab (Herceptin®) weekly or every 3 weeks beginning concurrently with paclitaxel OR 3 months after the last dose of paclitaxel and continuing for up to 52 weeks. In all arms, patients with estrogen-receptor or progesterone-receptor positive tumors receive hormonal therapy beginning within 28 days of the completion of adjuvant chemotherapy or radiotherapy (if given). After finishing study treatment patients are followed up every 6 months for 5 years and then once a year for up to 15 years. PROJECTED ACCRUAL: A total of 3,250 patients will be accrued for this study.

Interventions

BIOLOGICALpegfilgrastim

Given IV

DRUGAC regimen

Given IV

DRUGcyclophosphamide

Given IV

DRUGdoxorubicin hydrochloride

Given IV

DRUGpaclitaxel

Given IV

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed stage I-III invasive breast cancer * Operable disease * Stage I, II, IIIA, and IIIC (T1-3, N3a only) * No T4 tumors * High-risk disease, defined by 1 of the following: * Tumor ≥ 2 cm in greatest diameter (includes both invasive and intraductal component) * Patients with nodal status of N0+ (i.e., no cluster of tumor cells in any node greater than 0.2 mm) are considered to be node negative and must have a primary tumor ≥ 2 cm in size or have a tumor ≥ 1 cm with high risk features * Patients who are node negative on the basis of a sentinel node procedure and fewer than 6 axillary nodes are removed are eligible OR at least 6 axillary or intramammary nodes must be negative * Tumor ≥ 1 cm in diameter and meeting 1 of the following criteria: * ER-negative and PgR-negative * ER-positive or PgR-positive with a Genomic Health Recurrence Score of ≥ 26 * One or more axillary or intramammary nodes are involved by metastatic breast cancer * If one or more nodes is involved, a minimum of 6 axillary or intramammary nodes must have been examined histologically * Patients with N0(I+) disease will be considered node negative * HER2/neu-positive tumors (3+ by immunohistochemical staining or amplified by fluorescence in-situ hybridization) allowed * Bilateral synchronous breast cancer diagnosed within 1 month of each other allowed provided the higher TNM stage primary tumor meets the eligibility criteria * Prior modified radical mastectomy OR local excision of all tumors with axillary lymph node dissection or sentinel node resection required * No more than 84 days since prior surgery for the primary tumor and/or axilla * Final resection margins for the primary tumor must be histologically negative for invasive cancer and ductal carcinoma in situ * Resection margins positive for lobular carcinoma in situ are allowed * Hormone receptor status: * Estrogen receptor status known * Progesterone receptor status known PATIENT CHARACTERISTICS: Age * 18 and over Sex * Male or female Menopausal status * Not specified Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,200/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * Alkaline phosphatase no greater than 2 times ULN * SGOT or SGPT no greater than 2 times ULN Renal * Creatinine no greater than ULN Cardiovascular * No congestive heart failure * No active angina pectoris * LVEF greater than or equal to the lower limit of normal\* by MUGA or echocardiogram NOTE: Patients age 60 and over OR with a history of hypertension Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical carcinoma, or lobular carcinoma in situ of the breast * Prior invasive breast cancer or ductal carcinoma in situ allowed if disease-free for 5 years * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior cytotoxic chemotherapy for this breast cancer * No prior chemotherapy with an anthracycline, anthracenedione, or taxane Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy for this malignancy * At least 2 weeks since prior radiotherapy for ductal carcinoma in situ Surgery * See Disease Characteristics

Design outcomes

Primary

Measure	Time frame	Description
Disease-free Survival	every 6 months (annually for mammograms) for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Overall Survival	Every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.

Secondary

Measure	Time frame	Description
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Toxicity assessment was evaluated every 4 weeks while on protocol therapy.	Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.
Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group	Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years	Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.
Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.	Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years	Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.

Countries

Canada, Puerto Rico, United States

Contacts

STUDY_CHAIRGeorge Thomas Budd, MD

The Cleveland Clinic

STUDY_DIRECTORHalle C Moore, MD

The Cleveland Clinic

Participant flow

Participants by arm

Arm	Count
Arm I (closed 11/10/10) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim subcutaneously (SC) on day 2 or filgrastim (G-CSF) SC on days 3-10. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. pegfilgrastim: Given IV AC regimen: Given IV cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV paclitaxel: Given IV	664
Arm II (closed 11/10/10) Patients receive doxorubicin IV on day 1, oral cyclophosphamide on days 1-7, and G-CSF SC on days 2-7. Treatment repeats every 7 days for 15 courses. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel and pegfilgrastim as in arm I. pegfilgrastim: Given IV AC regimen: Given IV cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV paclitaxel: Given IV	683
Arm III (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and pegfilgrastim or G-CSF as in arm I. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses. pegfilgrastim: Given IV AC regimen: Given IV cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV paclitaxel: Given IV	681
Arm IV (closed 11/10/10) Patients receive doxorubicin, cyclophosphamide, and G-CSF as in arm II. Beginning 2 weeks after completion of cyclophosphamide, patients receive paclitaxel as in arm III. pegfilgrastim: Given IV AC regimen: Given IV cyclophosphamide: Given IV doxorubicin hydrochloride: Given IV paclitaxel: Given IV	639
Arm V (reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 3 hours on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses.	277
ARM VI (reopened in 12/2010) Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients receive doxorubicin IV and cyclophosphamide IV on day 1 and pegfilgrastim SC on day 2. Treatment repeats every 14 days for 6 courses. Beginning 2 weeks after completion of doxorubicin and cyclophosphamide, patients receive paclitaxel IV over 1 hour on day 1. Treatment repeats every 7 days for 12 courses.	294
Total	3,238

Baseline characteristics

Characteristic	Total	Arm I	Arm II	Arm III	Arm IV	Arm V	ARM VI
Age, Continuous	52.7 years	50.5 years	50.9 years	51.8 years	50.7 years	52.7 years	53.2 years
Black Race	377 Participants	73 Participants	77 Participants	74 Participants	78 Participants	31 Participants	44 Participants
ER/PgR Negative (both negative)	1083 Participants	212 Participants	226 Participants	232 Participants	206 Participants	99 Participants	108 Participants
ER/PgR Positive (either or both positive)	2145 Participants	450 Participants	456 Participants	446 Participants	430 Participants	178 Participants	185 Participants
ER/PgR Unknown	10 Participants	2 Participants	1 Participants	3 Participants	3 Participants	0 Participants	1 Participants
HER2 Negative	2606 Participants	528 Participants	556 Participants	554 Participants	525 Participants	208 Participants	235 Participants
HER2 Positive	601 Participants	125 Participants	123 Participants	118 Participants	109 Participants	69 Participants	57 Participants
HER2 Unknown	31 Participants	11 Participants	4 Participants	9 Participants	5 Participants	0 Participants	2 Participants
Menopausal status (females) Postmenopausal	1705 Participants	332 Participants	354 Participants	368 Participants	337 Participants	148 Participants	166 Participants
Menopausal status (females) Premenopausal	1505 Participants	326 Participants	325 Participants	308 Participants	299 Participants	124 Participants	123 Participants
Menopausal status (females) Unknown	5 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	2 Participants
Nodal status 1-3 positive nodes	1248 Participants	260 Participants	266 Participants	276 Participants	245 Participants	103 Participants	98 Participants
Nodal status >= 4 positive nodes	1147 Participants	241 Participants	264 Participants	243 Participants	244 Participants	68 Participants	87 Participants
Nodal status Negative	833 Participants	161 Participants	153 Participants	159 Participants	146 Participants	105 Participants	109 Participants
Nodal status unknown	10 Participants	2 Participants	0 Participants	3 Participants	4 Participants	1 Participants	0 Participants
Sex: Female, Male Female	3215 Participants	658 Participants	679 Participants	676 Participants	636 Participants	275 Participants	291 Participants
Sex: Female, Male Male	23 Participants	6 Participants	4 Participants	5 Participants	3 Participants	2 Participants	3 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
other Total, other adverse events	381 / 654	412 / 663	389 / 674	391 / 624	131 / 275	126 / 291
serious Total, serious adverse events	10 / 654	8 / 663	17 / 674	9 / 624	5 / 275	8 / 291

Outcome results

Primary

Disease-free Survival

Disease-free survival (DFS) defined as time from registration (randomization assignment) to first instance of disease recurrence (local, regional, or distant), new breast primary tumor, or death as a result of any cause. The results are entered as disease free survival at year 5.

Time frame: every 6 months (annually for mammograms) for 5 years

Population: Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.

Arm	Measure	Value (NUMBER)
Arm I	Disease-free Survival	83 percentage of participants
Arm II	Disease-free Survival	79 percentage of participants
Arm III	Disease-free Survival	81 percentage of participants
Arm IV	Disease-free Survival	81 percentage of participants
Arm V	Disease-free Survival	84 percentage of participants
Arm VI	Disease-free Survival	85 percentage of participants

p-value: 0.02295% CI: [1.04, 1.68]Log Rank

p-value: 0.07295% CI: [0.98, 1.59]Log Rank

p-value: 0.3895% CI: [0.87, 1.44]Log Rank

p-value: 0.11Log Rank

p-value: 0.73395% CI: [0.61, 1.41]Log Rank

Primary

Overall Survival

Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.

Time frame: Every 6 months for 5 years

Population: Only eligible and analyzable patients were included in this analysis. Two patients in Arm II and one patient in Arm IV with no follow-up were excluded.

Arm	Measure	Value (NUMBER)
Arm I	Overall Survival	90 percentage of participants
Arm II	Overall Survival	87 percentage of participants
Arm III	Overall Survival	87 percentage of participants
Arm IV	Overall Survival	87 percentage of participants
Arm V	Overall Survival	90 percentage of participants
Arm VI	Overall Survival	91 percentage of participants

p-value: 0.01395% CI: [1.08, 1.93]Log Rank

p-value: 0.01195% CI: [1.09, 1.95]Log Rank

p-value: 0.1795% CI: [0.91, 1.68]Log Rank

p-value: 0.04Log Rank

p-value: 0.72495% CI: [0.54, 1.53]Log Rank

Secondary

Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group

Time frame: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years

Population: Patients with HER2-positive at baseline in each arm were included in this analysis. One patient in Arm II with no follow-up was excluded. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.

Arm	Measure	Value (NUMBER)
Arm I	Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group	85 percentage of participants
Arm II	Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group	83 percentage of participants
Arm III	Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group	82 percentage of participants
Arm IV	Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group	80 percentage of participants

Comparison: Test of overall treatment differences.p-value: 0.69Log Rank

Comparison: Test of interaction two treatments: AC and paclitaxel.p-value: 0.66Log Rank

Secondary

Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group

Time frame: Biomarkers were measured by gene expression analysis before study entry. DFS was measured every 6 months for 5 years

Population: Patients with HR-negative, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.

Arm	Measure	Value (NUMBER)
Arm I	Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	83 percentage of participants
Arm II	Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	71 percentage of participants
Arm III	Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	72 percentage of participants
Arm IV	Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	75 percentage of participants

Comparison: Test of overall treatment differences.p-value: 0.076Log Rank

Comparison: Test of interaction of two treatments: AC and paclitaxel.p-value: 0.018Log Rank

Secondary

Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group

Time frame: Biomarkers were measured by gene expression analysis before study entry. DFS were measured every 6 months for 5 years

Population: Patients with HR-positive, HER-2 negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.

Arm	Measure	Value (NUMBER)
Arm I	Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	82 percentage of participants
Arm II	Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	82 percentage of participants
Arm III	Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	86 percentage of participants
Arm IV	Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	85 percentage of participants

Comparison: Overall treatment differences.p-value: 0.67Log Rank

Comparison: Test of interaction of two treatments: AC and paclitaxel.p-value: 0.42Log Rank

Secondary

Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Time frame: Toxicity assessment was evaluated every 4 weeks while on protocol therapy.

Population: Limited to patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed.

Arm	Measure	Group	Value (NUMBER)
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Paranasal	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	FEV(1)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fatigue (asthenia, lethargy, malaise)	77 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Joint-function	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Middle ear	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Febrile neutropenia	49 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Meninges	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fever in absence of neutropenia, ANC lt1.0x10e9/L	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lung	4 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fistula, GI - Oral cavity	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-high (hypernatremia)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fracture	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Colon	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	GGT (gamma-glutamyl transpeptidase)	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seroma	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Blood	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastritis (including bile reflux gastritis)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Metabolic/Laboratory-Other	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Bladder	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastrointestinal-Other	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ileus, GI (functional obstruction of bowel)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-high (hyperglycemia)	13 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	INR (of prothrombin time)	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypoxia	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-low (hypoglycemia)	4 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypotension	4 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hair loss/Alopecia (scalp or body)	3 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seizure	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypertension	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hot flashes/flushes	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Heartburn/dyspepsia	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhoids	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemoglobin	87 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Secondary Malignancy-poss rel to cancer Tx	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage/Bleeding-Other	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, pulmonary/upper respiratory - Nose	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Lower GI NOS	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Vagina	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Oral cavity	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Voice changes/dysarthria	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Urinary NOS	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Upper GI NOS	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Rectum	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - depression	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Anus	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Salivary gland changes/saliva	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Oral cav	11 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Sinus tachycardia	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Rectum	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myocarditis	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Viral hepatitis	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - SVT tachycardia	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nail changes	4 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Atrial fibrillation	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rigors/chills	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neurology-Other	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Restrictive cardiomyopathy	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN V Motor-jaw muscles; Sensory-facial	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: hand-foot skin reaction	19 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN VIII Hearing and balance	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: acne/acneiform	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Abdomen NOS	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash/desquamation	4 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Back	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Bone	10 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - Ventricular tachycardia	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pulmonary/Upper Respiratory-Other	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Psychosis (hallucinations/delusions)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Breast	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pruritus/itching	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Proteinuria	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Esophagus	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Dental	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Head/headache	5 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Prolapse of stoma, GI	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-low (hypokalemia)	18 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Joint	39 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - PVCs	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Middle ear	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-high (hyperkalemia)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Lung	7 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pneumonitis/pulmonary infiltrates	8 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pleural effusion (non-malignant)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Platelets	24 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Phosphate, serum-low (hypophosphatemia)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Wound complication, non-infectious	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pericardial effusion (non-malignant)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vasovagal episode	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain-Other	3 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Uterus	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Right ventricular dysfunction (cor pulmonale)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Stomach	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Skin	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vision-blurred vision	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Valvular heart disease	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	ALT, SGPT (serum glutamic pyruvic transaminase)	7 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Rectum	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pelvis	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	AST, SGOT	5 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vaginitis (not due to infection)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pain NOS	3 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Acidosis (metabolic or respiratory)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neuralgia/peripheral nerve	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neck	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Adult respiratory distress syndrome (ARDS)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - UTI	5 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Muscle	42 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Kidney	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Albumin, serum-low (hypoalbuminemia)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Extremity-limb	4 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Alkaline phosphatase	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Weight loss	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Dental/teeth/peridontal	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Allergic reaction/hypersensitivity	8 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest/thorax NOS	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest wall	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Anorexia	6 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - Extrem-lower	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Apnea	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Urticaria (hives, welts, wheals)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Pharynx	4 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Cardiac/heart	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Arthritis (non-septic)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Esophagus	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ataxia (incoordination)	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bilirubin (hyperbilirubinemia)	3 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Anus	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	PTT (Partial thromboplastin time)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bladder spasms	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Flu-like syndrome	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Opportunistic inf associated w/gt=Gr 2 lymphopenia	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Blood/Bone Marrow-Other	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Uric acid, serum-high (hyperuricemia)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obstruction, GI - Small bowel NOS	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obesity	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bronchospasm, wheezing	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neutrophils/granulocytes (ANC/AGC)	174 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	CNS cerebrovascular ischemia	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Rectum	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: sensory	107 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: motor	10 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-high (hypercalcemia)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN XII Motor-tongue	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-low (hypocalcemia)	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN VII Motor-face; Sensory-taste	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac General-Other	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Watery eye (epiphora, tearing)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nausea	50 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nasal cavity/paranasal sinus reactions	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin I (cTnI)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Pharynx	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin T (cTnT)	3 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with normal ANC or Grade 1 or 2 neutroph	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Oral cavity	17 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Esophagus	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac-ischemia/infarction	3 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Anus	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - anxiety	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiopulmonary arrest, cause unknown (non-fatal)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - agitation	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cataract	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Appendix	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Magnesium, serum-low (hypomagnesemia)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Lymphopenia	24 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cholecystitis	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Liver dysfunction/failure (clinical)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myelodysplasia	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vomiting	31 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Musculoskeletal/Soft Tissue-Other	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis, infectious (e.g., Clostridium difficile)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Esophagus	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - body/general	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Leukocytes (total WBC)	128 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Conduction abnormality - Asystole	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular systolic dysfunction	7 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Confusion	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/thrombus/embolism	10 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular diastolic dysfunction	3 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Irregular menses (change from baseline)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Peripheral sensory NOS	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constipation	3 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Insomnia	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constitutional Symptoms-Other	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Skin	3 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection-Other	4 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Wound	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cough	3 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/embolism (vascular access-related)	9 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Skin (cellulitis)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Creatinine	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Lung (pneumonia)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Kidney	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cystitis	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Taste alteration (dysgeusia)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Foreign body (e.g., g	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cytokine release syndrome/acute infusion reaction	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Catheter-related	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Blood	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	DIC (disseminated intravascular coagulation)	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Injection site reaction/extravasation changes	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death - Multi-organ failure	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - perioral	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Wound	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death not associated with CTCAE term - Death NOS	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syndromes-Other	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vulva	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vagina	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dehydration	8 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Up airway	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Ungual	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dermatology/Skin-Other	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Diarrhea	27 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Skin	7 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Distention/bloating, abdominal	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Sinus	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dizziness	5 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syncope (fainting)	5 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Neck NOS	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dysphagia (difficulty swallowing)	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Muscle	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Meninges	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dyspnea (shortness of breath)	21 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Spinal cord	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Kidney	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: head and neck	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Esophagus	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: limb	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sudden death	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Colon	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Catheter	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Encephalopathy	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Endocrine-Other	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Somnolence/depressed level of consciousness	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Blood	2 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bladder	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Esophagitis	5 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extrapyramidal/involuntary movement/restlessness	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Wound	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extremity-upper (function)	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - UTI	1 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Eyelid dysfunction	0 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-low (hyponatremia)	7 Participants
Arm I	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Arthritis (non-septic)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Uric acid, serum-high (hyperuricemia)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	FEV(1)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-high (hypernatremia)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Esophagus	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cough	5 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fatigue (asthenia, lethargy, malaise)	59 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Breast	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Neck NOS	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Middle ear	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ataxia (incoordination)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Back	5 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Febrile neutropenia	9 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Joint-function	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Meninges	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Anus	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Skin (cellulitis)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fever in absence of neutropenia, ANC lt1.0x10e9/L	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Liver dysfunction/failure (clinical)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bilirubin (hyperbilirubinemia)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lung	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vagina	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Eyelid dysfunction	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fistula, GI - Oral cavity	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Wound complication, non-infectious	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Flu-like syndrome	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	PTT (Partial thromboplastin time)	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Lung (pneumonia)	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Colon	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Muscle	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fracture	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seroma	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bladder spasms	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Creatinine	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Opportunistic inf associated w/gt=Gr 2 lymphopenia	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	GGT (gamma-glutamyl transpeptidase)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Taste alteration (dysgeusia)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Blood	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obstruction, GI - Small bowel NOS	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Bladder	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Endocrine-Other	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastritis (including bile reflux gastritis)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Blood/Bone Marrow-Other	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Kidney	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dysphagia (difficulty swallowing)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obesity	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastrointestinal-Other	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Metabolic/Laboratory-Other	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ileus, GI (functional obstruction of bowel)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sudden death	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	INR (of prothrombin time)	5 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cystitis	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-high (hyperglycemia)	17 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Voice changes/dysarthria	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bronchospasm, wheezing	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypoxia	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Rectum	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neutrophils/granulocytes (ANC/AGC)	156 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-low (hypoglycemia)	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seizure	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypotension	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypertension	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: sensory	101 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hair loss/Alopecia (scalp or body)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Foreign body (e.g., g	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	CNS cerebrovascular ischemia	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hot flashes/flushes	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Meninges	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Catheter-related	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Heartburn/dyspepsia	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Secondary Malignancy-poss rel to cancer Tx	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhoids	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: motor	13 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage/Bleeding-Other	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - UTI	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemoglobin	48 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cytokine release syndrome/acute infusion reaction	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-high (hypercalcemia)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, pulmonary/upper respiratory - Nose	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syndromes-Other	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN XII Motor-tongue	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Lower GI NOS	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - anxiety	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Vagina	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bladder	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Urinary NOS	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN VIII Hearing and balance	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Oral cavity	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Blood	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-low (hypocalcemia)	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Upper GI NOS	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN VII Motor-face; Sensory-taste	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Rectum	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Salivary gland changes/saliva	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dyspnea (shortness of breath)	18 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - depression	6 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Viral hepatitis	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nausea	40 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Anus	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac General-Other	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Sinus tachycardia	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	DIC (disseminated intravascular coagulation)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Oral cav	38 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Lung	5 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - SVT tachycardia	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nasal cavity/paranasal sinus reactions	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myocarditis	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Kidney	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin I (cTnI)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Atrial fibrillation	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Esophagus	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nail changes	12 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Pharynx	5 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rigors/chills	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - perioral	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Oral cavity	56 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neurology-Other	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Restrictive cardiomyopathy	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extremity-upper (function)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin T (cTnT)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN V Motor-jaw muscles; Sensory-facial	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: hand-foot skin reaction	95 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death - Multi-organ failure	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Injection site reaction/extravasation changes	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: acne/acneiform	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Esophagus	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash/desquamation	5 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Esophagitis	4 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Abdomen NOS	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - Ventricular tachycardia	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Wound	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pulmonary/Upper Respiratory-Other	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac-ischemia/infarction	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with normal ANC or Grade 1 or 2 neutroph	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Bone	36 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Anus	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: head and neck	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Spinal cord	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death not associated with CTCAE term - Death NOS	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pruritus/itching	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiopulmonary arrest, cause unknown (non-fatal)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Cardiac/heart	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - PVCs	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Proteinuria	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vomiting	29 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - agitation	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Esophagus	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Esophagus	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Prolapse of stoma, GI	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Magnesium, serum-low (hypomagnesemia)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Head/headache	8 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Dental	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vulva	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-low (hypokalemia)	12 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cataract	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Irregular menses (change from baseline)	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Colon	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Lymphopenia	31 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Middle ear	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Muscle	48 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-high (hyperkalemia)	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Rectum	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dehydration	7 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pneumonitis/pulmonary infiltrates	7 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cholecystitis	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pleural effusion (non-malignant)	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Appendix	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Platelets	21 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syncope (fainting)	5 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Phosphate, serum-low (hypophosphatemia)	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myelodysplasia	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Up airway	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pericardial effusion (non-malignant)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: limb	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain-Other	5 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Psychosis (hallucinations/delusions)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vasovagal episode	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-low (hyponatremia)	4 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Valvular heart disease	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Uterus	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Musculoskeletal/Soft Tissue-Other	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Wound	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Right ventricular dysfunction (cor pulmonale)	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Weight loss	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Stomach	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - body/general	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Skin	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dermatology/Skin-Other	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis, infectious (e.g., Clostridium difficile)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vision-blurred vision	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Peripheral sensory NOS	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	ALT, SGPT (serum glutamic pyruvic transaminase)	4 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vaginitis (not due to infection)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Leukocytes (total WBC)	98 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pelvis	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Catheter	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Skin	6 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	AST, SGOT	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Conduction abnormality - Asystole	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pain NOS	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/thrombus/embolism	7 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neuralgia/peripheral nerve	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular systolic dysfunction	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Acidosis (metabolic or respiratory)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Urticaria (hives, welts, wheals)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Paranasal	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neck	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular diastolic dysfunction	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Diarrhea	18 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Adult respiratory distress syndrome (ARDS)	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Confusion	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extrapyramidal/involuntary movement/restlessness	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Kidney	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Sinus	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Encephalopathy	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Albumin, serum-low (hypoalbuminemia)	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - UTI	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Joint	40 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Extremity-limb	9 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Distention/bloating, abdominal	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Skin	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Alkaline phosphatase	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constipation	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Dental/teeth/peridontal	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/embolism (vascular access-related)	18 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest/thorax NOS	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Insomnia	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Allergic reaction/hypersensitivity	12 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Ungual	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Somnolence/depressed level of consciousness	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest wall	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection-Other	3 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Anorexia	5 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Watery eye (epiphora, tearing)	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - Extrem-lower	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constitutional Symptoms-Other	1 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Rectum	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Apnea	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Pharynx	4 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Wound	0 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dizziness	2 Participants
Arm II	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Blood	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ataxia (incoordination)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Diarrhea	24 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Meninges	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Sinus	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - UTI	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Ungual	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vagina	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with normal ANC or Grade 1 or 2 neutroph	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Appendix	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Lung (pneumonia)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Peripheral sensory NOS	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Irregular menses (change from baseline)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Liver dysfunction/failure (clinical)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Metabolic/Laboratory-Other	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - anxiety	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - depression	4 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Esophagus	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myocarditis	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Abdomen NOS	5 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Bone	15 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Cardiac/heart	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Esophagus	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Head/headache	10 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Muscle	21 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Rectum	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pleural effusion (non-malignant)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Psychosis (hallucinations/delusions)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: acne/acneiform	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: hand-foot skin reaction	16 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Right ventricular dysfunction (cor pulmonale)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vision-blurred vision	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	ALT, SGPT (serum glutamic pyruvic transaminase)	3 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	AST, SGOT	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Acidosis (metabolic or respiratory)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Adult respiratory distress syndrome (ARDS)	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Albumin, serum-low (hypoalbuminemia)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Alkaline phosphatase	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Allergic reaction/hypersensitivity	6 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Anorexia	8 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Apnea	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Arthritis (non-septic)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bilirubin (hyperbilirubinemia)	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bladder spasms	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Blood/Bone Marrow-Other	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bronchospasm, wheezing	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	CNS cerebrovascular ischemia	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-high (hypercalcemia)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-low (hypocalcemia)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac General-Other	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin I (cTnI)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin T (cTnT)	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac-ischemia/infarction	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiopulmonary arrest, cause unknown (non-fatal)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cataract	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cholecystitis	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis, infectious (e.g., Clostridium difficile)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Conduction abnormality - Asystole	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Confusion	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constipation	3 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constitutional Symptoms-Other	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cough	4 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Creatinine	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cystitis	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cytokine release syndrome/acute infusion reaction	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	DIC (disseminated intravascular coagulation)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death - Multi-organ failure	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death not associated with CTCAE term - Death NOS	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dehydration	12 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dermatology/Skin-Other	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Distention/bloating, abdominal	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dizziness	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dysphagia (difficulty swallowing)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dyspnea (shortness of breath)	25 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: head and neck	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: limb	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Encephalopathy	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Endocrine-Other	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Esophagitis	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extrapyramidal/involuntary movement/restlessness	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extremity-upper (function)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Eyelid dysfunction	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	FEV(1)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fatigue (asthenia, lethargy, malaise)	87 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Febrile neutropenia	38 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fever in absence of neutropenia, ANC lt1.0x10e9/L	3 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fistula, GI - Oral cavity	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Flu-like syndrome	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fracture	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	GGT (gamma-glutamyl transpeptidase)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastritis (including bile reflux gastritis)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastrointestinal-Other	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-high (hyperglycemia)	9 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-low (hypoglycemia)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hair loss/Alopecia (scalp or body)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Heartburn/dyspepsia	3 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemoglobin	101 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Lower GI NOS	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Oral cavity	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Rectum	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Upper GI NOS	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Urinary NOS	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Vagina	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, pulmonary/upper respiratory - Nose	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage/Bleeding-Other	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhoids	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hot flashes/flushes	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypertension	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypotension	4 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypoxia	3 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	INR (of prothrombin time)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ileus, GI (functional obstruction of bowel)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Bladder	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Blood	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Colon	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lung	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Meninges	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Middle ear	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Paranasal	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Skin	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - UTI	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Wound	3 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bladder	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Blood	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Catheter	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Colon	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Dental	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Esophagus	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Kidney	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Lung	10 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Muscle	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Neck NOS	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Skin	8 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Up airway	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vulva	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Wound	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - perioral	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Blood	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Catheter-related	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Foreign body (e.g., g	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Kidney	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Skin (cellulitis)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Wound	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection-Other	5 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Injection site reaction/extravasation changes	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Insomnia	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Spinal cord	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Joint-function	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular diastolic dysfunction	3 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular systolic dysfunction	8 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Leukocytes (total WBC)	157 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - body/general	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Musculoskeletal/Soft Tissue-Other	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myelodysplasia	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Lymphopenia	26 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Magnesium, serum-low (hypomagnesemia)	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - agitation	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Anus	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Esophagus	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Oral cavity	23 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nail changes	5 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Pharynx	3 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nasal cavity/paranasal sinus reactions	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nausea	53 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neurology-Other	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN V Motor-jaw muscles; Sensory-facial	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN VII Motor-face; Sensory-taste	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN VIII Hearing and balance	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN XII Motor-tongue	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: motor	8 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: sensory	76 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neutrophils/granulocytes (ANC/AGC)	218 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obesity	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obstruction, GI - Small bowel NOS	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Opportunistic inf associated w/gt=Gr 2 lymphopenia	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	PTT (Partial thromboplastin time)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Anus	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Back	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Breast	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Anus	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Oral cav	28 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Pharynx	5 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Rectum	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - Extrem-lower	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest wall	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest/thorax NOS	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Dental/teeth/peridontal	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Extremity-limb	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Joint	21 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Kidney	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Middle ear	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neck	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neuralgia/peripheral nerve	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pain NOS	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pelvis	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Skin	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Stomach	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Uterus	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain-Other	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pericardial effusion (non-malignant)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Phosphate, serum-low (hypophosphatemia)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Platelets	20 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pneumonitis/pulmonary infiltrates	11 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-high (hyperkalemia)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-low (hypokalemia)	18 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Prolapse of stoma, GI	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Proteinuria	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pruritus/itching	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pulmonary/Upper Respiratory-Other	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash/desquamation	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Restrictive cardiomyopathy	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rigors/chills	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Atrial fibrillation	5 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - SVT tachycardia	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Sinus tachycardia	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Salivary gland changes/saliva	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Secondary Malignancy-poss rel to cancer Tx	4 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seizure	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seroma	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-high (hypernatremia)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-low (hyponatremia)	5 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Somnolence/depressed level of consciousness	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sudden death	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syncope (fainting)	7 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syndromes-Other	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Taste alteration (dysgeusia)	2 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/embolism (vascular access-related)	10 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/thrombus/embolism	9 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Esophagus	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Rectum	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Uric acid, serum-high (hyperuricemia)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Urticaria (hives, welts, wheals)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vaginitis (not due to infection)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Valvular heart disease	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vasovagal episode	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - PVCs	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - Ventricular tachycardia	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Viral hepatitis	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Voice changes/dysarthria	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vomiting	38 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Watery eye (epiphora, tearing)	0 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Weight loss	1 Participants
Arm III	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Wound complication, non-infectious	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Skin	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extremity-upper (function)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Somnolence/depressed level of consciousness	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - UTI	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extrapyramidal/involuntary movement/restlessness	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Wound	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Esophagitis	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Spinal cord	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bladder	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Endocrine-Other	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vomiting	17 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Blood	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Encephalopathy	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sudden death	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Catheter	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: limb	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Colon	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Peripheral sensory NOS	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Dental	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: head and neck	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Esophagus	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Kidney	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dyspnea (shortness of breath)	16 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syncope (fainting)	5 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Lung	5 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dysphagia (difficulty swallowing)	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dizziness	5 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Neck NOS	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Injection site reaction/extravasation changes	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Distention/bloating, abdominal	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Skin	11 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dermatology/Skin-Other	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - UTI	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Ungual	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dehydration	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syndromes-Other	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Up airway	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death not associated with CTCAE term - Death NOS	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vulva	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Wound	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death - Multi-organ failure	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection-Other	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - perioral	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	DIC (disseminated intravascular coagulation)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with normal ANC or Grade 1 or 2 neutroph	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Middle ear	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cytokine release syndrome/acute infusion reaction	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Taste alteration (dysgeusia)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Catheter-related	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cystitis	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Foreign body (e.g., g	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Kidney	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Creatinine	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cough	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Lung (pneumonia)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Skin (cellulitis)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Wound	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constitutional Symptoms-Other	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/embolism (vascular access-related)	6 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constipation	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Insomnia	6 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Joint-function	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Confusion	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Blood	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular diastolic dysfunction	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Conduction abnormality - Asystole	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Wound complication, non-infectious	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular systolic dysfunction	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/thrombus/embolism	8 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Leukocytes (total WBC)	128 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis, infectious (e.g., Clostridium difficile)	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - body/general	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Musculoskeletal/Soft Tissue-Other	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Appendix	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myelodysplasia	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cholecystitis	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Lymphopenia	32 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cataract	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Watery eye (epiphora, tearing)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Magnesium, serum-low (hypomagnesemia)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiopulmonary arrest, cause unknown (non-fatal)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Esophagus	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - depression	4 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac-ischemia/infarction	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Anus	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Esophagus	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nail changes	9 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin T (cTnT)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Oral cavity	57 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin I (cTnI)	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Pharynx	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Rectum	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nasal cavity/paranasal sinus reactions	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac General-Other	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neurology-Other	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vagina	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN V Motor-jaw muscles; Sensory-facial	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-low (hypocalcemia)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN VII Motor-face; Sensory-taste	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN VIII Hearing and balance	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-high (hypercalcemia)	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Uric acid, serum-high (hyperuricemia)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN XII Motor-tongue	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: motor	6 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	CNS cerebrovascular ischemia	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: sensory	56 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bronchospasm, wheezing	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neutrophils/granulocytes (ANC/AGC)	201 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obesity	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Blood/Bone Marrow-Other	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obstruction, GI - Small bowel NOS	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bladder spasms	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Urticaria (hives, welts, wheals)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Opportunistic inf associated w/gt=Gr 2 lymphopenia	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	PTT (Partial thromboplastin time)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bilirubin (hyperbilirubinemia)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Anus	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Back	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Bone	9 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fistula, GI - Oral cavity	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Anus	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Arthritis (non-septic)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vaginitis (not due to infection)	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Oral cav	40 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Apnea	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Pharynx	4 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Rectum	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Anorexia	4 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Sinus	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Joint	12 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest wall	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Allergic reaction/hypersensitivity	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest/thorax NOS	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Alkaline phosphatase	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Valvular heart disease	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Dental/teeth/peridontal	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Extremity-limb	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Albumin, serum-low (hypoalbuminemia)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Kidney	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Muscle	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Middle ear	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Adult respiratory distress syndrome (ARDS)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Muscle	11 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Weight loss	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Acidosis (metabolic or respiratory)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vasovagal episode	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neuralgia/peripheral nerve	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	AST, SGOT	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pain NOS	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pelvis	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	ALT, SGPT (serum glutamic pyruvic transaminase)	4 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Skin	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Viral hepatitis	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Right ventricular dysfunction (cor pulmonale)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: hand-foot skin reaction	94 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Uterus	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: acne/acneiform	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - PVCs	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pleural effusion (non-malignant)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pericardial effusion (non-malignant)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Phosphate, serum-low (hypophosphatemia)	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain-Other	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Meninges	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Platelets	22 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Stomach	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Rectum	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pneumonitis/pulmonary infiltrates	5 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neck	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-high (hyperkalemia)	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - Ventricular tachycardia	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-low (hypokalemia)	7 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Head/headache	10 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Prolapse of stoma, GI	4 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Esophagus	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Cardiac/heart	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Proteinuria	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Breast	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pruritus/itching	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Psychosis (hallucinations/delusions)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pulmonary/Upper Respiratory-Other	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Abdomen NOS	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Diarrhea	23 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash/desquamation	4 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vision-blurred vision	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Restrictive cardiomyopathy	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rigors/chills	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nausea	33 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Atrial fibrillation	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myocarditis	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - SVT tachycardia	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Esophagus	5 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Sinus tachycardia	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - anxiety	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ataxia (incoordination)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Salivary gland changes/saliva	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Voice changes/dysarthria	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Secondary Malignancy-poss rel to cancer Tx	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Rectum	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - agitation	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Upper GI NOS	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Oral cavity	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Metabolic/Laboratory-Other	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Urinary NOS	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Lower GI NOS	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Vagina	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seizure	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, pulmonary/upper respiratory - Nose	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemoglobin	47 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage/Bleeding-Other	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Heartburn/dyspepsia	5 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhoids	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hot flashes/flushes	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hair loss/Alopecia (scalp or body)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypertension	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-low (hypoglycemia)	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypotension	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seroma	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypoxia	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-high (hyperglycemia)	13 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	INR (of prothrombin time)	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastrointestinal-Other	3 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ileus, GI (functional obstruction of bowel)	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Liver dysfunction/failure (clinical)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastritis (including bile reflux gastritis)	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Bladder	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	GGT (gamma-glutamyl transpeptidase)	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Blood	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-high (hypernatremia)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fracture	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Colon	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Flu-like syndrome	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lung	4 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fever in absence of neutropenia, ANC lt1.0x10e9/L	1 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Irregular menses (change from baseline)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Febrile neutropenia	20 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Meninges	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-low (hyponatremia)	4 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fatigue (asthenia, lethargy, malaise)	65 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	FEV(1)	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Paranasal	2 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - Extrem-lower	0 Participants
Arm IV	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Eyelid dysfunction	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN VIII Hearing and balance	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Arthritis (non-septic)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - depression	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-high (hypercalcemia)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Skin	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Upper GI NOS	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extremity-upper (function)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Esophagus	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ileus, GI (functional obstruction of bowel)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin I (cTnI)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pneumonitis/pulmonary infiltrates	3 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seizure	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - UTI	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extrapyramidal/involuntary movement/restlessness	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Somnolence/depressed level of consciousness	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neck	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lung	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Oral cav	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Colon	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Apnea	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage/Bleeding-Other	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Wound	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vaginitis (not due to infection)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Esophagitis	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN XII Motor-tongue	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-high (hyperkalemia)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Watery eye (epiphora, tearing)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - anxiety	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Endocrine-Other	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Heartburn/dyspepsia	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Rectum	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bladder	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	CNS cerebrovascular ischemia	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Head/headache	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Anorexia	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastritis (including bile reflux gastritis)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Uric acid, serum-high (hyperuricemia)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Blood	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nail changes	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Encephalopathy	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-low (hypokalemia)	8 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Cardiac/heart	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fatigue (asthenia, lethargy, malaise)	20 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myocarditis	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: limb	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sudden death	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin T (cTnT)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Catheter	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Allergic reaction/hypersensitivity	5 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - Ventricular tachycardia	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac General-Other	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhoids	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Colon	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Prolapse of stoma, GI	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest wall	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Dental	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: head and neck	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: sensory	45 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Injection site reaction/extravasation changes	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Secondary Malignancy-poss rel to cancer Tx	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Esophagus	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Wound complication, non-infectious	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bronchospasm, wheezing	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dyspnea (shortness of breath)	2 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vomiting	8 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest/thorax NOS	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Kidney	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Urinary NOS	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Proteinuria	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Alkaline phosphatase	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Lung	2 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hair loss/Alopecia (scalp or body)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Up airway	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dysphagia (difficulty swallowing)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Meninges	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac-ischemia/infarction	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Breast	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Dental/teeth/peridontal	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syncope (fainting)	5 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dizziness	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neutrophils/granulocytes (ANC/AGC)	57 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Esophagus	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Neck NOS	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nasal cavity/paranasal sinus reactions	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	FEV(1)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Distention/bloating, abdominal	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Spinal cord	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pruritus/itching	2 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Albumin, serum-low (hypoalbuminemia)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Valvular heart disease	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hot flashes/flushes	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Extremity-limb	4 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Diarrhea	8 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Blood/Bone Marrow-Other	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection-Other	2 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Flu-like syndrome	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Skin	4 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Joint	11 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dermatology/Skin-Other	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Bladder	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Lower GI NOS	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Psychosis (hallucinations/delusions)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obesity	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - UTI	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Adult respiratory distress syndrome (ARDS)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Muscle	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Bone	15 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Ungual	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Esophagus	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dehydration	4 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Kidney	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Rectum	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiopulmonary arrest, cause unknown (non-fatal)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Magnesium, serum-low (hypomagnesemia)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vagina	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Middle ear	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death not associated with CTCAE term - Death NOS	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pulmonary/Upper Respiratory-Other	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syndromes-Other	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fistula, GI - Oral cavity	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Voice changes/dysarthria	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vulva	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypertension	2 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Muscle	10 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death - Multi-organ failure	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obstruction, GI - Small bowel NOS	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	GGT (gamma-glutamyl transpeptidase)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Wound	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Rectum	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Acidosis (metabolic or respiratory)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bladder spasms	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Salivary gland changes/saliva	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-low (hypoglycemia)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - perioral	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Vagina	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	DIC (disseminated intravascular coagulation)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash/desquamation	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Lung (pneumonia)	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Esophagus	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with normal ANC or Grade 1 or 2 neutroph	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neuralgia/peripheral nerve	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Appendix	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Opportunistic inf associated w/gt=Gr 2 lymphopenia	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	AST, SGOT	4 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cytokine release syndrome/acute infusion reaction	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: motor	5 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: acne/acneiform	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN V Motor-jaw muscles; Sensory-facial	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vasovagal episode	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypotension	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Catheter-related	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pain NOS	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cystitis	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN VII Motor-face; Sensory-taste	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Taste alteration (dysgeusia)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-high (hypernatremia)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Foreign body (e.g., g	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bilirubin (hyperbilirubinemia)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	ALT, SGPT (serum glutamic pyruvic transaminase)	3 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Creatinine	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Urticaria (hives, welts, wheals)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-low (hypocalcemia)	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Kidney	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pelvis	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neurology-Other	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	PTT (Partial thromboplastin time)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Abdomen NOS	5 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cough	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-low (hyponatremia)	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Blood	2 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Restrictive cardiomyopathy	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Skin (cellulitis)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Rectum	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Oral cavity	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constitutional Symptoms-Other	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemoglobin	21 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Viral hepatitis	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Wound	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Anus	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Right ventricular dysfunction (cor pulmonale)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-high (hyperglycemia)	6 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Febrile neutropenia	16 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Eyelid dysfunction	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Sinus tachycardia	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fever in absence of neutropenia, ANC lt1.0x10e9/L	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constipation	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: hand-foot skin reaction	3 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/embolism (vascular access-related)	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nausea	9 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Insomnia	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypoxia	3 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Peripheral sensory NOS	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Weight loss	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Confusion	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Blood	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vision-blurred vision	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Joint-function	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Anus	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Uterus	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ataxia (incoordination)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rigors/chills	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Middle ear	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular diastolic dysfunction	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Conduction abnormality - Asystole	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Irregular menses (change from baseline)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pleural effusion (non-malignant)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seroma	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular systolic dysfunction	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - PVCs	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Back	2 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis, infectious (e.g., Clostridium difficile)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fracture	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Atrial fibrillation	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pericardial effusion (non-malignant)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - agitation	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, pulmonary/upper respiratory - Nose	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/thrombus/embolism	3 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - Extrem-lower	2 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - body/general	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain-Other	4 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Oral cavity	4 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	INR (of prothrombin time)	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue	1 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Musculoskeletal/Soft Tissue-Other	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Phosphate, serum-low (hypophosphatemia)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Sinus	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cholecystitis	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - SVT tachycardia	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myelodysplasia	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Leukocytes (total WBC)	38 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Pharynx	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Stomach	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Liver dysfunction/failure (clinical)	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastrointestinal-Other	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Meninges	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cataract	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Platelets	6 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Pharynx	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Lymphopenia	15 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Paranasal	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Anus	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Skin	0 Participants
Arm V	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Metabolic/Laboratory-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Right ventricular dysfunction (cor pulmonale)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Sinus tachycardia	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac-ischemia/infarction	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - anxiety	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Pharynx	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - depression	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Flu-like syndrome	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Anus	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin T (cTnT)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myelodysplasia	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Esophagus	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - perioral	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Salivary gland changes/saliva	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Esophagus	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mood alteration - agitation	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac troponin I (cTnI)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (clinical exam) - Oral cavity	3 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Colon	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nail changes	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiac General-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Secondary Malignancy-poss rel to cancer Tx	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nasal cavity/paranasal sinus reactions	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-low (hypocalcemia)	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ulcer, GI - Rectum	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Rectum	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Oral cavity	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN V Motor-jaw muscles; Sensory-facial	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Up airway	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Paranasal	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Calcium, serum-high (hypercalcemia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Watery eye (epiphora, tearing)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN VIII Hearing and balance	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Upper GI NOS	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-high (hypernatremia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: cranial - CN XII Motor-tongue	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	CNS cerebrovascular ischemia	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GI - Lower GI NOS	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sodium, serum-low (hyponatremia)	3 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bronchospasm, wheezing	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Uric acid, serum-high (hyperuricemia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: sensory	25 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Urinary NOS	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neutrophils/granulocytes (ANC/AGC)	65 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Blood/Bone Marrow-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Soft tiss	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obesity	3 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Eye NOS	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bladder spasms	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Obstruction, GI - Small bowel NOS	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fever in absence of neutropenia, ANC lt1.0x10e9/L	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, GU - Vagina	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Opportunistic inf associated w/gt=Gr 2 lymphopenia	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Bilirubin (hyperbilirubinemia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemoglobin	19 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Abdomen NOS	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ataxia (incoordination)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Urticaria (hives, welts, wheals)	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Back	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Arthritis (non-septic)	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage, pulmonary/upper respiratory - Nose	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Anus	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Heartburn/dyspepsia	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Breast	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Apnea	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Esophagus	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Oral cav	6 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhage/Bleeding-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Anorexia	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vaginitis (not due to infection)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Rectum	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lung	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seizure	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Cardiac/heart	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Allergic reaction/hypersensitivity	5 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Muscle	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest wall	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hemorrhoids	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Alkaline phosphatase	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hair loss/Alopecia (scalp or body)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Chest/thorax NOS	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Magnesium, serum-low (hypomagnesemia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Febrile neutropenia	14 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Dental/teeth/peridontal	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Esophagus	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Albumin, serum-low (hypoalbuminemia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hot flashes/flushes	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Valvular heart disease	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Joint	5 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Adult respiratory distress syndrome (ARDS)	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Kidney	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-low (hypoglycemia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Middle ear	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Eyelid dysfunction	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Muscle	5 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Acidosis (metabolic or respiratory)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypertension	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neck	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	AST, SGOT	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Voice changes/dysarthria	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Neuralgia/peripheral nerve	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Lymphatic	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pain NOS	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	ALT, SGPT (serum glutamic pyruvic transaminase)	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vasovagal episode	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypotension	3 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Pelvis	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Glucose, serum-high (hyperglycemia)	5 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Rectum	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Viral hepatitis	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Kidney	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Colon	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Stomach	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Hypoxia	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Uterus	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pleural effusion (non-malignant)	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastrointestinal-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Spinal cord	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pericardial effusion (non-malignant)	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - PVCs	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Phosphate, serum-low (hypophosphatemia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	INR (of prothrombin time)	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Platelets	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Seroma	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Skin	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Meninges	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Pharynx	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Wound complication, non-infectious	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bil. tree	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Skin	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Soft tissue	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extrapyramidal/involuntary movement/restlessness	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pneumonitis/pulmonary infiltrates	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Upper airway	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ileus, GI (functional obstruction of bowel)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Esophagitis	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Somnolence/depressed level of consciousness	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Weight loss	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Wound	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Gastritis (including bile reflux gastritis)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-high (hyperkalemia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Endocrine-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Intra-operative injury - Peripheral sensory NOS	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Head/headache	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bladder	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Encephalopathy	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fatigue (asthenia, lethargy, malaise)	14 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Blood	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Potassium, serum-low (hypokalemia)	8 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Bronchus	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: limb	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Extremity-limb	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Catheter	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Edema: head and neck	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Sudden death	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Prolapse of stoma, GI	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Dental	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Abdomen NOS	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Extremity-upper (function)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Esophagus	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dyspnea (shortness of breath)	4 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Ventricular arrhythmia - Ventricular tachycardia	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	GGT (gamma-glutamyl transpeptidase)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Proteinuria	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Lung	4 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dysphagia (difficulty swallowing)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Meninges	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dizziness	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Irregular menses (change from baseline)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syncope (fainting)	7 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Neck NOS	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Distention/bloating, abdominal	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Oral cav	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pruritus/itching	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Diarrhea	6 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Sinus	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dermatology/Skin-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Bone	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Skin	4 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vomiting	6 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Psychosis (hallucinations/delusions)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - UTI	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Dehydration	4 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Ungual	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pain - Anus	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - UTI	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Bladder	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death not associated with CTCAE term - Death NOS	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vagina	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Insomnia	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Pulmonary/Upper Respiratory-Other	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Vulva	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Death - Multi-organ failure	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Syndromes-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils - Wound	3 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	PTT (Partial thromboplastin time)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	DIC (disseminated intravascular coagulation)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	FEV(1)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Middle ear	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils -Nerve-cran	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash/desquamation	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: motor	8 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with normal ANC or Grade 1 or 2 neutroph	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Appendix	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cytokine release syndrome/acute infusion reaction	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cystitis	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: acne/acneiform	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neuropathy: CN VII Motor-face; Sensory-taste	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Catheter-related	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rash: hand-foot skin reaction	4 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Foreign body (e.g., g	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Creatinine	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Taste alteration (dysgeusia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Neurology-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Kidney	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cough	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Lung (pneumonia)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Skin (cellulitis)	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constitutional Symptoms-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Blood	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Restrictive cardiomyopathy	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection with unknown ANC - Wound	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Constipation	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fistula, GI - Oral cavity	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Infection-Other	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Metabolic/Laboratory-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Injection site reaction/extravasation changes	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nausea	9 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Confusion	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/embolism (vascular access-related)	4 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Joint-function	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Blood	3 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Conduction abnormality - Asystole	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Rigors/chills	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular diastolic dysfunction	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Fracture	2 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Myocarditis	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Vision-blurred vision	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Left ventricular systolic dysfunction	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis, infectious (e.g., Clostridium difficile)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - Extrem-lower	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - Atrial fibrillation	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Colitis	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Muscle weakness, not d/t neuropathy - body/general	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Mucositis/stomatitis (functional/symp) - Pharynx	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Thrombosis/thrombus/embolism	4 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Musculoskeletal/Soft Tissue-Other	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cholecystitis	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Leukocytes (total WBC)	34 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	SVT and nodal arrhythmia - SVT tachycardia	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Liver dysfunction/failure (clinical)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cataract	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf w/normal ANC or Gr 1-2 neutrophils-Foreign bod	1 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Lymphopenia	18 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Cardiopulmonary arrest, cause unknown (non-fatal)	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel	0 Participants
Arm VI	Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Inf (clin/microbio) w/Gr 3-4 neuts - Mucosa	0 Participants

Secondary

Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.

Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.

Time frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years

Arm	Measure	Value (NUMBER)
Arm I	Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.	94 percentage of participants
Arm II	Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.	89 percentage of participants
Arm III	Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.	89 percentage of participants
Arm IV	Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.	88 percentage of participants

Comparison: Test of overall treatment differencesp-value: 0.4Log Rank

Comparison: Test of interaction of two treatments: AC and paclitaxel.p-value: 0.28Log Rank

Secondary

Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group

Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.

Time frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years

Population: Patients with HR-negative, HER2-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.

Arm	Measure	Value (NUMBER)
Arm I	Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	85 percentage of participants
Arm II	Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	76 percentage of participants
Arm III	Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	78 percentage of participants
Arm IV	Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group	82 percentage of participants

Comparison: Test of overall treatment differences.p-value: 0.062Log Rank

Comparison: Test of interaction of two treatments: AC and paclitaxel.p-value: 0.01Log Rank

Secondary

Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group

Overall survival defined as time from registration to death as result of any cause. Results were entered as overall survival rate at year 5.

Time frame: Biomarkers were measured by gene expression analysis before study entry. OS was measured every 6 months for 5 years

Population: Patients with HR-positive, HER-negative at baseline in each arm were included in this analysis. Arm V and Arm VI were reopened under a new revised protocol and the data were not mature. And the results for Arm V and Arm VI will be reported in a subsequent publication.

Arm	Measure	Value (NUMBER)
Arm I	Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	91 percentage of participants
Arm II	Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	92 percentage of participants
Arm III	Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	91 percentage of participants
Arm IV	Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group	90 percentage of participants

Comparison: Test of overall treatment differences.p-value: 0.9Log Rank

Comparison: Test of interaction of two treatments: AC and paclitaxel.p-value: 0.52Log Rank

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026

S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer

Conditions

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Brief summary

Detailed description

Related papers

Interventions

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Study design

Eligibility

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Design outcomes

Primary

Secondary

Countries

Contacts

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Disease-free Survival

Overall Survival

Disease-free Survival Comparison Between 2 Treatments in HER2-positive Group

Disease-free Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group

Disease-free Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group

Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

Overall Survival Comparison Between 2 Treatments in HER-2 Positive Group.

Overall Survival Comparison Between 2 Treatments in HR-negative, HER-2 Negative Group

Overall Survival Comparison Between 2 Treatments in HR-positive, HER-2 Negative Group