S1314, Co-expression Extrapolation (COXEN) Program to Pre... | NCT02177695

NCT02177695

ID	Type	Description	Link
S1314	Other Identifier	SWOG
NCI-2014-00850	Other Identifier	National Cancer Institute
U10CA180888	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gemcitabine & Cisplatin	Experimental	Gemcitabine, 1000 mg/m2, IV, Days 1&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles	Drug: Gemcitabine Drug: Cisplatin
Dose Dense MVAC	Experimental	Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles	Drug: Cisplatin Drug: Methotrexate Drug: Vinblastine Drug: Doxorubicin Drug: Filgrastim

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gemcitabine	Drug	Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of Whether the Treatment-specific COXEN Score is Prognostic of pT0 Rate	The proportion of participants achieving pT0 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved pT0 _____________________________________________________________________________________________________________________ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . By evaluating the correlation between the GC- and the DDMVAC-COXEN score.	Up to 5 years post registration
Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate	The proportion of participants achieving <=pT1 in both favorable and unfavorable treatment specific-COXEN score categories. Unit of measure is the number of participants in each category that achieved <= pT1 ____________________________________________________________________________________________________________________ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores This will be done in two ways: By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. . By evaluating the correlation between the GC- and the DDMVAC-COXEN score.	up to 5 years post-registration
Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC

Secondary Outcomes

Measure	Description	Time Frame
Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)	In addition to stratification factors and dichotomous COXEN GEM score, an indicator for treatment arm and the interaction of treatment arm with COXEN GEM score was also included in a logistic regression model. A significant interaction would suggest that the respective COXEN GEM score was able to differentiate whether a patient was more likely to respond to one chemotherapy regimen over another. *note that this is the same objective at Primary Outcome #3 above - this was erroneously listed twice in the protocol.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically proven bladder cancer (pure small cell carcinoma, pure adenocarcinoma, and pure squamous cell carcinoma histologies are excluded).
Stage cT2-T4a N0 M0 disease.
Documented muscle invasive disease with at least one of the following: disease measuring at least 10 mm on cross-sectional imaging OR the presence of tumor-associated hydronephrosis.
Staging scans with abdominal/pelvic CT or MRI scan and CT scan or x-ray of the chest within 56 days prior to registration. If alkaline phosphatase is above the treating institution's upper limit of normal (ULN), presence of suspicious bone pain, or if other clinical suspicion, a whole body bone scan is required within 56 days prior to registration.
Performance status = 0 or 1
18 years of age or older
Must have tumor tissue from transurethral resection of the bladder tumor (TURBT) available for submission that is sufficient for COXEN testing and must agree to submission of 20 (10 micron) slides plus 2 (5 micron) slides from the start and end of the 20 slides for a total of 22 unstained slides.
Must agree to collection of tissue (if residual disease is present), urine, and whole blood.
Must agree to participate in the translational medicine studies outlined in the protocol

Exclusion Criteria:

Prior systemic cytotoxic chemotherapy or systemic anthracycline
Peripheral neuropathy >/= Grade 2
Class III/IV heart failure or known left ventricular ejection fraction (LVEF) < 50%
Clinically relevant hearing impairment > Grade 2
Renal function, calculated creatinine clearance < 60 mL/min
Hepatic function, total bilirubin > 1.5 x institutional upper limit of normal (IULN) (or > 2.5 x IULN with Gilbert's disease); AST & ALT > 2 X IULN
Hematologic function, absolute neutrophil count (ANC) < 1,500/mcL, hemoglobin < 9 g/dL, and platelets < 100,000/mcL
Hypersensitivity to cisplatin, gemcitabine, doxorubicin, vinblastine, methotrexate, or filgrastim/pegfilgrastim
Incidence of or uncontrolled medical illness (e.g. active cardiac symptoms, active systemic infection, etc.)
Pregnant or nursing females
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. However, patients with localized prostate cancer who are being followed by an active surveillance program are eligible.

Contacts/Locations Module

Name	Affiliation	Role
Thomas W. Flaig, M.D.	University of Colorado, Denver	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham Cancer Center		Birmingham	Alabama	35233	United States
Fairbanks Memorial Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40121304	Derived	Bai Z, Osman M, Brendel M, Tangen CM, Flaig TW, Thompson IM, Plets M, Scott Lucia M, Theodorescu D, Gustafson D, Daneshmand S, Meeks JJ, Choi W, Dinney CPN, Elemento O, Lerner SP, McConkey DJ, Faltas BM, Wang F. Predicting response to neoadjuvant chemotherapy in muscle-invasive bladder cancer via interpretable multimodal deep learning. NPJ Digit Med. 2025 Mar 22;8(1):174. doi: 10.1038/s41746-025-01560-y.
37414705	Derived	Flaig TW, Tangen CM, Daneshmand S, Alva AS, Lucia MS, McConkey DJ, Theodorescu D, Goldkorn A, Milowsky MI, Bangs R, MacVicar GR, Bastos BR, Fowles JS, Gustafson DL, Plets M, Thompson IM Jr, Lerner SP. Long-term Outcomes from a Phase 2 Study of Neoadjuvant Chemotherapy for Muscle-invasive Bladder Cancer (SWOG S1314; NCT02177695). Eur Urol. 2023 Sep;84(3):341-347. doi: 10.1016/j.eururo.2023.06.014. Epub 2023 Jul 4.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Gemcitabine & Cisplatin	Gemcitabine, 1000 mg/m2, IV, Days 1&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle). Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP_ICF	Yes	Yes	Yes	Study Protocol, Statistical Analysis Plan, and Informed Consent Form	Jul 15, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Gemcitabine & Cisplatin

To assess in a hypothesis generating fashion, the ability of COXEN to select for an individual chemotherapy regimen (GC vs DDMVAC)

P-values are reported as a measure of whether COXEN can select between GC/DDMVAC and to determine the significance of interactions between treatment specific COXEN scores and treatment arms in models predicting either pT0 or <= pT1. Interactions with p-values > 0.05 are interpreted as not significant.

________ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores

This will be done in two ways:

By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. .
By evaluating the correlation between the GC- and the DDMVAC-COXEN score.

All eligible participants

Arm/Group Information

ID	Title	Description
BG000	Gemcitabine & Cisplatin	Gemcitabine, 1000 mg/m2, IV, Days 1&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle). Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
BG001	Dose Dense MVAC	Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle). Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Full Range

years

Title

Denominators

Categories

Favorable treatment-COXEN score

- ParticipantsOG00018
- ParticipantsOG00130

Title	Measurements
	OG0008

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	To determine the relationship of GC COXEN scores to pT0, GC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the GC treatment group.	Regression, Logistic		0.1		Odds Ratio (OR)	2.63			2-Sided	95	0.82	8.36					Superiority
OG001

Primary

Assessment of Whether the Treatment-specific COXEN Score is Prognostic of ≤ pT1 Rate

The proportion of participants achieving <=pT1 in both favorable and unfavorable treatment specific-COXEN score categories.

Unit of measure is the number of participants in each category that achieved <= pT1

____________________________________________________________________________________________________________________ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores

This will be done in two ways:

By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. .
By evaluating the correlation between the GC- and the DDMVAC-COXEN score.

Eligible participants that were evaluable for COXEN analysis

Posted

Count of Participants

Participants

up to 5 years post-registration

ID	Title	Description
OG000	Gemcitabine & Cisplatin	Gemcitabine, 1000 mg/m2, IV, Days 1&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle). Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.

Primary

Assessment of COXEN Score as a Predictive Factor Distinguishing Between GC and ddMVAC

To assess in a hypothesis generating fashion, the ability of COXEN to select for an individual chemotherapy regimen (GC vs DDMVAC)

________ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores

This will be done in two ways:

By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. .
By evaluating the correlation between the GC- and the DDMVAC-COXEN score.

Eligible participants that were evaluable for COXEN analysis. Participants in this arm were pooled to test the ability of the COXEN algorithm to distinguish between GC and ddMVAC treatment, with the assumption that there is no interaction between the COXEN score and treatment arm.

Posted

Number

p-value

up to 5 years post-registration

ID	Title	Description
OG000	All Participants	Eligible participants that were evaluable for COXEN analysis

Primary

Correlation Between GC-and ddMVAC-COXEN Score

The Pearson and Spearman correlation coefficients for GC-and ddMVAC-COXEN score were calculated and are reported below.

___________________________________________________________________________________________________________________ The relationship of dose-dense methotrexate, vinblastin, doxorubicin, and cisplatin (DDMVAC)- and gemcitabine+cisplatin (GC)- specific CO-eXpression ExtrapolatioN (COXEN) scores

This will be done in two ways:

By assessing whether the treatment-specific COXEN score is prognostic of pT0 rate or ≤ pT1 in this patient population and to assess in a preliminary fashion whether the COXEN score is a predictive factor distinguishing between these two chemotherapy regimens. .
By evaluating the correlation between the GC- and the DDMVAC-COXEN score.

Posted

Number

correlation coefficient

up to 5 years post-registration

ID	Title	Description
OG000	All Participants	Eligible participants that were evaluable for COXEN analysis

Units	Counts

Secondary

Predictability of the CO-eXpression ExtrapolatioN (COXEN) Score to Direct Which of the Two Regimens the Patient Should Receive: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)

In addition to stratification factors and dichotomous COXEN GEM score, an indicator for treatment arm and the interaction of treatment arm with COXEN GEM score was also included in a logistic regression model. A significant interaction would suggest that the respective COXEN GEM score was able to differentiate whether a patient was more likely to respond to one chemotherapy regimen over another. *note that this is the same objective at Primary Outcome #3 above - this was erroneously listed twice in the protocol.

Posted

Number

p-value

Up to 5 years post registration

ID	Title	Description
OG000	All Participants	Eligible participants that were evaluable for COXEN analysis

Units	Counts
Participants

Secondary

Value of Gene Expression Profiling in Predicting Overall Survival (OS)

5-year OS curve was estimated using the Kaplan-Meier method. Included all COXEN evaluable participants regardless of arm assignment. The report groups were favorable vs. unfavorable COXEN status.

Eligible participants across both arms that were evaluable for COXEN analysis.

Posted

Number

Percent of Participants

Up to 5 years post registration

ID	Title	Description
OG000	All Participants	Eligible participants that were evaluable for COXEN analysis

Units	Counts
Participants	OG000

Secondary

Pathologic T0 Rate Evaluation: Gemcitabine+Cisplatin (GC) Versus Dose-dense Methotrexate, Vinblastin, Doxorubicin, and Cisplatin (DDMVAC)

Pathologic complete response rate at the time of cystectomy following GC or DDMVAC treatment

Participants who received treatment in Gemcitabine & Cisplatin and Dose Dense MVAC arms.

Posted

Number

percentage of participants

Up to 5 years post-registration

ID	Title	Description
OG000	Gemcitabine & Cisplatin	Gemcitabine, 1000 mg/m2, IV, Days 1&8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle). Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
OG001	Dose Dense MVAC	Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle). Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.

Secondary

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

Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. Grade 3 is less severe than Grade 5.

Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL* (bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden).

Grade 4 - Life-threatening consequences; urgent intervention indicated. Grade 5 - Death related to AE

*ADL- Activities of Daily Living

Participants who received at least one dose of protocol treatment, submitted toxicity data and were included in the ITT analysis.

Posted

Number

Participants

Duration of treatment and follow up until death or 5 years post registration

ID	Title	Description
OG000	Gemcitabine and Cisplatin	Gemcitabine, 1000 mg/m2, IV, Days 1 and 8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle). Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
OG001	Dose Dense MVAC

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Gemcitabine and Cisplatin	Gemcitabine, 1000 mg/m2, IV, Days 1 and 8, q 21 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1, q 21 days x 4 cycles Gemcitabine: Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle). Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.	28	115	1	115	112	115
EG001	Dose Dense MVAC	Methotrexate, 30 mg/m2, IV, Day 1, q 14 days x 4 cycles Vinblastine, 3 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Doxorubicin, 30 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Cisplatin, 70 mg/m2, IV, Day 1 or 2, q 14 days x 4 cycles Filgrastim, 5 mcg/kg, SubQ/IV, Days 3-7, q 14 days x 4 cycles Cisplatin: Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle). Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Methotrexate: Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Vinblastine: Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Doxorubicin: Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops. Filgrastim: Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.	25	112	4	112	108	112

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Upper gastrointestinal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Sudden death NOS	General disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Infections and infestations-Other	Infections and infestations	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	Systematic Assessment	EG00083 affected115 at risk EG00169 affected112 at risk
Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Systematic Assessment	EG0002 affected115 at risk EG0011 affected112 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 affected115 at risk EG0011 affected112 at risk
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Cardiac disorders-Other	Cardiac disorders	Systematic Assessment	EG0001 affected115 at risk EG0012 affected112 at risk
Chest pain - cardiac	Cardiac disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Heart failure	Cardiac disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Mitral valve disease	Cardiac disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Sinus tachycardia	Cardiac disorders	Systematic Assessment	EG0009 affected115 at risk EG0013 affected112 at risk
Ear and labyrinth disorders-Other	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected115 at risk EG0012 affected112 at risk
Ear pain	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Hearing impaired	Ear and labyrinth disorders	Systematic Assessment	EG0004 affected115 at risk EG0017 affected112 at risk
Tinnitus	Ear and labyrinth disorders	Systematic Assessment	EG00018 affected115 at risk EG00125 affected112 at risk
Vestibular disorder	Ear and labyrinth disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Hyperthyroidism	Endocrine disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Blurred vision	Eye disorders	Systematic Assessment	EG0006 affected115 at risk EG0016 affected112 at risk
Conjunctivitis	Eye disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Dry eye	Eye disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Eye disorders-Other	Eye disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Photophobia	Eye disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Watering eyes	Eye disorders	Systematic Assessment	EG0000 affected115 at risk EG0018 affected112 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG00012 affected115 at risk EG00110 affected112 at risk
Anal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Anal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Bloating	Gastrointestinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG00047 affected115 at risk EG00146 affected112 at risk
Diarrhea	Gastrointestinal disorders	Systematic Assessment	EG00019 affected115 at risk EG00127 affected112 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0002 affected115 at risk EG0014 affected112 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0006 affected115 at risk EG00110 affected112 at risk
Dysphagia	Gastrointestinal disorders	Systematic Assessment	EG0002 affected115 at risk EG0012 affected112 at risk
Esophageal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Esophagitis	Gastrointestinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Flatulence	Gastrointestinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	Systematic Assessment	EG00011 affected115 at risk EG00116 affected112 at risk
Gastrointestinal disorders-Other	Gastrointestinal disorders	Systematic Assessment	EG0004 affected115 at risk EG0014 affected112 at risk
Gastroparesis	Gastrointestinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Hemorrhoidal hemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Hemorrhoids	Gastrointestinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Mucositis oral	Gastrointestinal disorders	Systematic Assessment	EG00012 affected115 at risk EG00139 affected112 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG00065 affected115 at risk EG00172 affected112 at risk
Oral dysesthesia	Gastrointestinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Oral pain	Gastrointestinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0014 affected112 at risk
Stomach pain	Gastrointestinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG00018 affected115 at risk EG00128 affected112 at risk
Chills	General disorders	Systematic Assessment	EG0004 affected115 at risk EG0014 affected112 at risk
Edema face	General disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Edema limbs	General disorders	Systematic Assessment	EG00016 affected115 at risk EG00113 affected112 at risk
Fatigue	General disorders	Systematic Assessment	EG00082 affected115 at risk EG00177 affected112 at risk
Fever	General disorders	Systematic Assessment	EG00012 affected115 at risk EG0015 affected112 at risk
Flu like symptoms	General disorders	Systematic Assessment	EG0005 affected115 at risk EG0011 affected112 at risk
General disorders and admin site conditions - Other	General disorders	Systematic Assessment	EG0004 affected115 at risk EG0014 affected112 at risk
Infusion related reaction	General disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Infusion site extravasation	General disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Injection site reaction	General disorders	Systematic Assessment	EG0004 affected115 at risk EG0011 affected112 at risk
Irritability	General disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Localized edema	General disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Malaise	General disorders	Systematic Assessment	EG0002 affected115 at risk EG0012 affected112 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG0004 affected115 at risk EG0013 affected112 at risk
Pain	General disorders	Systematic Assessment	EG0007 affected115 at risk EG0018 affected112 at risk
Allergic reaction	Immune system disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Bladder infection	Infections and infestations	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Bronchial infection	Infections and infestations	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Enterocolitis infectious	Infections and infestations	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Eye infection	Infections and infestations	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Infections and infestations-Other	Infections and infestations	Systematic Assessment	EG0002 affected115 at risk EG0015 affected112 at risk
Kidney infection	Infections and infestations	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Lung infection	Infections and infestations	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Mucosal infection	Infections and infestations	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Phlebitis infective	Infections and infestations	Systematic Assessment	EG0002 affected115 at risk EG0010 affected112 at risk
Rash pustular	Infections and infestations	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Sinusitis	Infections and infestations	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Skin infection	Infections and infestations	Systematic Assessment	EG0002 affected115 at risk EG0013 affected112 at risk
Tooth infection	Infections and infestations	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Upper respiratory infection	Infections and infestations	Systematic Assessment	EG0003 affected115 at risk EG0012 affected112 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG00017 affected115 at risk EG00111 affected112 at risk
Bruising	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 affected115 at risk EG0012 affected112 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Alanine aminotransferase increased	Investigations	Systematic Assessment	EG00010 affected115 at risk EG0018 affected112 at risk
Alkaline phosphatase increased	Investigations	Systematic Assessment	EG00016 affected115 at risk EG00123 affected112 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0006 affected115 at risk EG0017 affected112 at risk
Blood bilirubin increased	Investigations	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Cholesterol high	Investigations	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Creatinine increased	Investigations	Systematic Assessment	EG00034 affected115 at risk EG00137 affected112 at risk
Hemoglobin increased	Investigations	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Investigations-Other	Investigations	Systematic Assessment	EG0004 affected115 at risk EG0013 affected112 at risk
Lymphocyte count decreased	Investigations	Systematic Assessment	EG00018 affected115 at risk EG00116 affected112 at risk
Neutrophil count decreased	Investigations	Systematic Assessment	EG00044 affected115 at risk EG00115 affected112 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG00050 affected115 at risk EG00137 affected112 at risk
Weight gain	Investigations	Systematic Assessment	EG0005 affected115 at risk EG0010 affected112 at risk
Weight loss	Investigations	Systematic Assessment	EG00011 affected115 at risk EG00111 affected112 at risk
White blood cell decreased	Investigations	Systematic Assessment	EG00042 affected115 at risk EG00114 affected112 at risk
Anorexia	Metabolism and nutrition disorders	Systematic Assessment	EG00028 affected115 at risk EG00135 affected112 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG00010 affected115 at risk EG0019 affected112 at risk
Glucose intolerance	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Hypercalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Hyperglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG00025 affected115 at risk EG00129 affected112 at risk
Hyperkalemia	Metabolism and nutrition disorders	Systematic Assessment	EG00010 affected115 at risk EG00110 affected112 at risk
Hypermagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Hypernatremia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Hypertriglyceridemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 affected115 at risk EG0013 affected112 at risk
Hypoalbuminemia	Metabolism and nutrition disorders	Systematic Assessment	EG00013 affected115 at risk EG00124 affected112 at risk
Hypocalcemia	Metabolism and nutrition disorders	Systematic Assessment	EG0009 affected115 at risk EG00116 affected112 at risk
Hypoglycemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 affected115 at risk EG0012 affected112 at risk
Hypokalemia	Metabolism and nutrition disorders	Systematic Assessment	EG00011 affected115 at risk EG00120 affected112 at risk
Hypomagnesemia	Metabolism and nutrition disorders	Systematic Assessment	EG00035 affected115 at risk EG00138 affected112 at risk
Hyponatremia	Metabolism and nutrition disorders	Systematic Assessment	EG00025 affected115 at risk EG00129 affected112 at risk
Hypophosphatemia	Metabolism and nutrition disorders	Systematic Assessment	EG0009 affected115 at risk EG0017 affected112 at risk
Metabolism and nutrition disorders - Other, specify	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected115 at risk EG0013 affected112 at risk
Obesity	Metabolism and nutrition disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0009 affected115 at risk EG00113 affected112 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00010 affected115 at risk EG00110 affected112 at risk
Bone pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00011 affected115 at risk EG0018 affected112 at risk
Flank pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 affected115 at risk EG0011 affected112 at risk
Generalized muscle weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00011 affected115 at risk EG0019 affected112 at risk
Muscle weakness lower limb	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Musculoskeletal and connective tiss disorder - Other	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected115 at risk EG0012 affected112 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0005 affected115 at risk EG0014 affected112 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00011 affected115 at risk EG0017 affected112 at risk
Tumor pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Amnesia	Nervous system disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Concentration impairment	Nervous system disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG00015 affected115 at risk EG00117 affected112 at risk
Dysgeusia	Nervous system disorders	Systematic Assessment	EG00019 affected115 at risk EG00124 affected112 at risk
Headache	Nervous system disorders	Systematic Assessment	EG00018 affected115 at risk EG00119 affected112 at risk
Memory impairment	Nervous system disorders	Systematic Assessment	EG0001 affected115 at risk EG0012 affected112 at risk
Nervous system disorders-Other	Nervous system disorders	Systematic Assessment	EG0002 affected115 at risk EG0010 affected112 at risk
Paresthesia	Nervous system disorders	Systematic Assessment	EG0001 affected115 at risk EG0013 affected112 at risk
Peripheral motor neuropathy	Nervous system disorders	Systematic Assessment	EG0003 affected115 at risk EG0012 affected112 at risk
Peripheral sensory neuropathy	Nervous system disorders	Systematic Assessment	EG00011 affected115 at risk EG00114 affected112 at risk
Presyncope	Nervous system disorders	Systematic Assessment	EG0002 affected115 at risk EG0010 affected112 at risk
Sinus pain	Nervous system disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Somnolence	Nervous system disorders	Systematic Assessment	EG0003 affected115 at risk EG0014 affected112 at risk
Stroke	Nervous system disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0003 affected115 at risk EG0012 affected112 at risk
Tremor	Nervous system disorders	Systematic Assessment	EG0003 affected115 at risk EG0012 affected112 at risk
Agitation	Psychiatric disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG00013 affected115 at risk EG0013 affected112 at risk
Confusion	Psychiatric disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0007 affected115 at risk EG0013 affected112 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG00023 affected115 at risk EG00116 affected112 at risk
Libido decreased	Psychiatric disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Psychiatric disorders-Other	Psychiatric disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0006 affected115 at risk EG0017 affected112 at risk
Bladder spasm	Renal and urinary disorders	Systematic Assessment	EG0002 affected115 at risk EG0012 affected112 at risk
Chronic kidney disease	Renal and urinary disorders	Systematic Assessment	EG0006 affected115 at risk EG0013 affected112 at risk
Cystitis noninfective	Renal and urinary disorders	Systematic Assessment	EG0003 affected115 at risk EG0010 affected112 at risk
Hematuria	Renal and urinary disorders	Systematic Assessment	EG00017 affected115 at risk EG00113 affected112 at risk
Proteinuria	Renal and urinary disorders	Systematic Assessment	EG0004 affected115 at risk EG0012 affected112 at risk
Renal and urinary disorders-Other	Renal and urinary disorders	Systematic Assessment	EG0004 affected115 at risk EG0013 affected112 at risk
Urinary frequency	Renal and urinary disorders	Systematic Assessment	EG00014 affected115 at risk EG0014 affected112 at risk
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Urinary tract obstruction	Renal and urinary disorders	Systematic Assessment	EG0001 affected115 at risk EG0012 affected112 at risk
Urinary tract pain	Renal and urinary disorders	Systematic Assessment	EG0007 affected115 at risk EG0018 affected112 at risk
Urinary urgency	Renal and urinary disorders	Systematic Assessment	EG0002 affected115 at risk EG0011 affected112 at risk
Dyspareunia	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Erectile dysfunction	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Pelvic pain	Reproductive system and breast disorders	Systematic Assessment	EG0003 affected115 at risk EG0013 affected112 at risk
Prostatic obstruction	Reproductive system and breast disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Reproductive system and breast disorders - Other	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Scrotal pain	Reproductive system and breast disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Allergic rhinitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected115 at risk EG0011 affected112 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0007 affected115 at risk EG00110 affected112 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00013 affected115 at risk EG0016 affected112 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 affected115 at risk EG00111 affected112 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00013 affected115 at risk EG00113 affected112 at risk
Hoarseness	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0012 affected112 at risk
Laryngeal inflammation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Laryngeal mucositis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0015 affected112 at risk
Pharyngeal mucositis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Postnasal drip	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0013 affected112 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 affected115 at risk EG0011 affected112 at risk
Resp, thoracic and mediastinal disorders - Other	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Sinus disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Sore throat	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 affected115 at risk EG0016 affected112 at risk
Alopecia	Skin and subcutaneous tissue disorders	Systematic Assessment	EG00019 affected115 at risk EG00148 affected112 at risk
Bullous dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Dry skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Erythema multiforme	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected115 at risk EG0012 affected112 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Nail discoloration	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Pain of skin	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected115 at risk EG0011 affected112 at risk
Photosensitivity	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0004 affected115 at risk EG0011 affected112 at risk
Rash acneiform	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 affected115 at risk EG0013 affected112 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0008 affected115 at risk EG0016 affected112 at risk
Skin and subcutaneous tissue disorders - Other	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0004 affected115 at risk EG0017 affected112 at risk
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Social circumstances-Other	Social circumstances	Systematic Assessment	EG0001 affected115 at risk EG0012 affected112 at risk
Flushing	Vascular disorders	Systematic Assessment	EG0001 affected115 at risk EG0010 affected112 at risk
Hot flashes	Vascular disorders	Systematic Assessment	EG0002 affected115 at risk EG0013 affected112 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG00023 affected115 at risk EG00130 affected112 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0005 affected115 at risk EG0012 affected112 at risk
Phlebitis	Vascular disorders	Systematic Assessment	EG0002 affected115 at risk EG0010 affected112 at risk
Superficial thrombophlebitis	Vascular disorders	Systematic Assessment	EG0002 affected115 at risk EG0010 affected112 at risk
Thromboembolic event	Vascular disorders	Systematic Assessment	EG00011 affected115 at risk EG0014 affected112 at risk
Vascular disorders-Other	Vascular disorders	Systematic Assessment	EG0000 affected115 at risk EG0011 affected112 at risk

ID	Term
D001749	Urinary Bladder Neoplasms

Ancestor Terms

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052801	Male Urogenital Diseases

ID	Term
D000093542	Gemcitabine
D002945	Cisplatin
D008727	Methotrexate
D014747	Vinblastine
D004317	Doxorubicin
D000069585	Filgrastim

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017672	Nitrogen Compounds
D017671	Platinum Compounds
D000630	Aminopterin
D011622	Pterins
D011621	Pteridines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D014748	Vinca Alkaloids
D046948	Secologanin Tryptamine Alkaloids
D026121	Indole Alkaloids
D000470	Alkaloids
D007211	Indoles
D054836	Indolizidines
D007212	Indolizines
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates
D016179	Granulocyte Colony-Stimulating Factor
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D016298	Hematopoietic Cell Growth Factors
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

BG00064.9(34.5 to 79.2)

BG00164.8(33.1 to 86.5)

BG00264.8(33.1 to 86.5)

ParticipantsBG002167

To determine the relationship of ddMVAC COXEN scores to pT0, ddMVAC COXEN score (dichotomous, favorable vs. unfavorable) was tested in a logistic regression model predicting the outcome of pT0 within the ddMVAC treatment group.