Gemcitabine, Cisplatin, Plus Nivolumab in Patients With M... | NCT03558087

NCT03558087

Status Module

Sponsor/Collaborators Module

Name	Class
Bristol-Myers Squibb	INDUSTRY
Icahn School of Medicine at Mount Sinai	OTHER

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 and Nivolumab	Experimental	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy.	Drug: Nivolumab Drug: Gemcitabine Drug: Cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nivolumab	Drug	Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Complete Response (CCR) Rate	Clinical complete response rate will be defined as the percentage of patients who achieved cT0 or cTa disease after gemcitabine, cisplatin, plus nivolumab.	24 months
Predict Benefit From Treatment	Determine the ability of clinical complete response (cT0 or cTa) to predict benefit from treatment.Benefit will be defined as a pathologic complete response (\	24 months

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	The frequency and severity of all grade 3+ treatment-emergent adverse events occurring in at least 10% of patients are reported by CTCAEv4 term and grade.	AE had been recorded from time of signed informed consent until 100 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ECOG Performance Status of ≤ 1 within 28 days prior to registration.
Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder (i.e., ct2-4n0m0). candidate for cystectomy as per treating physician.
Demonstrate adequate organ function per listed criteria:
Absolute Neutrophil Count (ANC): ≥ 1.5 x 10^9/L
Hemoglobin (Hgb): ≥ 9 g/dL
Platelets: ≥ 100 x 10^9/L
Calculated creatinine clearance: Creatinine ≤ 1.5 or creatinine clearance ≥ 60 mL/min
Bilirubin: ≤ 1.5 × upper limit of normal (ULN) (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
Aspartate aminotransferase (AST) : ≤ 3 × ULN
Alanine aminotransferase (ALT) : ≤ 3 × ULN
All subjects must have adequate archival tissue identified at screening (i.e., at least 15 unstained slides or paraffin block). Subjects without available archival tissue must be discussed with the sponsor-investigator.
Women of childbearing potential must have a negative serum or urine pregnancy within 7 days prior to C1D1. NOTE: "Women of childbearing potential" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 62 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.

NOTE: Women of childbearing potential (WOCBP) receiving nivolumab must be willing to abstain from heterosexual intercourse or to use 2 forms of effective methods of contraception from the time of informed consent to 5 months after the last dose of nivolumab or for the timeframe outlined per package insert for chemotherapy. This timeframe also applies to breastfeeding. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method. Male subjects capable of fathering a child that are sexually active with partners of childbearing potential must be willing to abstain from heterosexual intercourse or to use 2 forms of effective methods of contraception from the time of informed consent to the timeframe outlined per package insert for chemotherapy. Contraception is not required for nivolumab. The timeframes described in the previous 2 sentences apply to sperm donation. Two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method.

Exclusion Criteria:

Prior treatment with systemic chemotherapy for muscle-invasive urothelial cancer of the bladder
Active infection requiring systemic therapy
Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results.
Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
Grade ≥ 2 neuropathy (NCI CTCAE version 4).
Prior radiation therapy for bladder cancer
Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (RNA) or hepatitis C antibody (HCV antibody) indicating acute or chronic infection.
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Evidence of interstitial lung disease or active, non-infectious pneumonitis.
Solid organ or allogeneic stem cell transplant

Contacts/Locations Module

Name	Affiliation	Role
Matthew Galsky, MD	Icahn School of Medicine at Mount Sinai	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope		Duarte	California	91010	United States
Univerity of Southern California

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Gemcitabine, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.

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	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Aug 12, 2021

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 and Nivolumab

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Gemcitabine, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.

Units	Counts
Participants	BG00076

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

Title	Measurements
	BG00069(39 to 85)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016
Male	BG00060

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000
Asian	BG0009

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00076

Clinical stage

Tumor Node Metastasis (TNM) Staging. This system classifies tumors by size and extent of the primary tumor (T), involvement of regional lymph nodes (N), and the presence or absence of distant metastases (M).

T0=No evidence of primary tumor, Tis=Carcinoma in situ, and T1, T2, T3, T4=Increasing size and/or local extension of the primary tumor, TX=Not assessed.

N0=No Regional lymph node metastases, N1, N2, N3=Increasing number or extent of regional lymph node involvement, NX=not assessed.

M0=No distant metastases, M1=Distant metastases present

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
cT2N0M0	BG00043
cT3N0M0	BG000

Histology

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Urothelial Cancer (UC)	BG00057
UC with squamous	BG0007

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Clinical Complete Response (CCR) Rate

Clinical complete response rate will be defined as the percentage of patients who achieved cT0 or cTa disease after gemcitabine, cisplatin, plus nivolumab.

Posted

Number

95% Confidence Interval

Percentage of participants

24 months

ID	Title	Description
OG000	Gemcitabine, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.

Units	Counts
Participants	OG00076

Title

Denominators

Categories

Title	Measurements
	OG00043(32 to 55)

Primary

Predict Benefit From Treatment

Determine the ability of clinical complete response (cT0 or cTa) to predict benefit from treatment.Benefit will be defined as a pathologic complete response (\

Among the 33 patients achieving a CCR, only one opted for immediate cystectomy with surgical pathology, revealing a low-grade ypTaN0 urothelial cancer (UC). Therefore 32 patients were used for this outcome measure.

Posted

Number

95% Confidence Interval

Proportion of CCR patients

24 months

ID	Title	Description
OG000	Gemcitabine, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.

Secondary

Adverse Events

The frequency and severity of all grade 3+ treatment-emergent adverse events occurring in at least 10% of patients are reported by CTCAEv4 term and grade.

Posted

Number

participants

AE had been recorded from time of signed informed consent until 100 days after discontinuation of study drug(s) or until a new anti-cancer treatment starts, whichever occurs first, up to a maximum of 13 months.

ID	Title	Description
OG000	Gemcitabine, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.

Units	Counts
Participants	OG000

Secondary

Bladder Intact Overall Survival

Bladder-intact overall survival is defined as the time from initiation of treatment until death or cystectomy.

Bladder-intact overall survival results are showing in accordance with CCR status. Out of 76 patients, 33 patients achieved a clinical complete response, and 43 patients did not achieve a clinical complete response.

Posted

Median

95% Confidence Interval

Months

Up to a maximum of 60 months

ID	Title	Description
OG000	Gemcitabine, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.

Units	Counts
Participants

Secondary

Recurrence-free Survival

Recurrence-free survival is defined as the time from initiation of treatment to death or recurrence, depending on which occurs first

Recurrence-free survival results are showing in accordance with CCR status. Out of 76 patients, 33 patients achieved a clinical complete response, and 43 patients did not achieve a clinical complete response.

Posted

Median

95% Confidence Interval

Months

Up to a maximum of 60 months

ID	Title	Description
OG000	Gemcitabine, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.

Units	Counts
Participants

Secondary

Pathologic Complete Response Rate in Patients Undergoing Cystectomy

Pathologic complete response rate in patients undergoing radical cystectomy is defined as the proportion of patients with \

Only 8 patients achieving a clinical complete response (CCR) later underwent cystectomy, and 34 patients not achieving a CCR underwent cystectomy.

Posted

Count of Participants

Participants

Up to a maximum of 53 months

ID	Title	Description
OG000	Gemcitabine, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.

Units	Counts
Participants

Secondary

Association Between a Prespecified Panel of Genomic Biomarkers and Benefit From Treatment in Patients Achieving a Clinical Complete Response.

Benefit will be defined as a pathologic complete response (p\

Posted

Number

95% Confidence Interval

Proportion of CCR patients

24 months

ID	Title	Description
OG000	Gemcitabine, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.

Secondary

Overall Survival

Overall survival is defined as the time from initiation of treatment to death.

Overall survival results are showing in accordance with CCR status. Out of 76 patients, 33 patients achieved a clinical complete response, and 43 patients did not achieve a clinical complete response.

Posted

Median

95% Confidence Interval

Months

Up to a maximum of 60 months

ID	Title	Description
OG000	Gemcitabine, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.

Units	Counts
Participants

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, Cisplatin and Nivolumab	Combination Therapy: Nivolumab 360mg IV, Gemcitabine 100mg/m^2 IV ,Cisplatin 70mg/m^2 IV for four 21-day cycles. At restaging, subjects with cT0 or cTa status may undergo cystectomy or continue maintenance Nivolumab 240mg IV for up to 8 14-day cycles. Subjects with > cTa status will undergo cystectomy. Nivolumab: Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days). Gemcitabine: Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles. Cisplatin: Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.	13	76	40	76	76	76

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ABDOMINAL PAIN	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG0005 events5 affected76 at risk
ADRENAL INSUFFICIENCY	Endocrine disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
ANEMIA	Blood and lymphatic system disorders	CTCAEv4	Non-systematic Assessment	EG0002 events1 affected76 at risk
ATRIAL FIBRILLATION	Cardiac disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	Blood and lymphatic system disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
BLOOD BILIRUBIN INCREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
DEPRESSION	Psychiatric disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
DYSPNEA	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0002 events1 affected76 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
FEVER	General disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
HEMATURIA	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
HYPERTHYROIDISM	Endocrine disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
HYPONATREMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG0004 events4 affected76 at risk
HYPOTENSION	Vascular disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0004 events3 affected76 at risk
KIDNEY INFECTION	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
LUNG INFECTION	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
PLATELET COUNT DECREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
RENAL AND URINARY DISORDERS - OTHER, SPECIFY	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG0003 events2 affected76 at risk
SEPSIS	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0006 events4 affected76 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
STROKE	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
THROMBOEMBOLIC EVENT	Vascular disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
URINARY TRACT INFECTION	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG00011 events10 affected76 at risk
VOMITING	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ABDOMINAL DISTENSION	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG00010 events8 affected76 at risk
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	Investigations	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG0005 events3 affected76 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG00017 events10 affected76 at risk
ALKALINE PHOSPHATASE INCREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG0006 events5 affected76 at risk
ALOPECIA	Skin and subcutaneous tissue disorders	CTCAEv4	Non-systematic Assessment	EG00020 events20 affected76 at risk
ANEMIA	Blood and lymphatic system disorders	CTCAEv4	Non-systematic Assessment	EG000146 events52 affected76 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
ANOREXIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG00025 events22 affected76 at risk
ANXIETY	Psychiatric disorders	CTCAEv4	Non-systematic Assessment	EG0006 events5 affected76 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG00021 events9 affected76 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	CTCAEv4	Non-systematic Assessment	EG00014 events13 affected76 at risk
BLOATING	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0005 events3 affected76 at risk
BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	Blood and lymphatic system disorders	CTCAEv4	Non-systematic Assessment	EG00027 events16 affected76 at risk
BLOOD BILIRUBIN INCREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG0003 events2 affected76 at risk
BLURRED VISION	Eye disorders	CTCAEv4	Non-systematic Assessment	EG0006 events4 affected76 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
BURN	Injury, poisoning and procedural complications	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
CHILLS	General disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
CHOLESTEROL HIGH	Investigations	CTCAEv4	Non-systematic Assessment	EG0004 events4 affected76 at risk
COGNITIVE DISTURBANCE	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
COLITIS	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
CONSTIPATION	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG00038 events35 affected76 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0006 events6 affected76 at risk
CREATININE INCREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG00064 events36 affected76 at risk
CYSTITIS NONINFECTIVE	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
DEHYDRATION	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG0004 events3 affected76 at risk
DEPRESSION	Psychiatric disorders	CTCAEv4	Non-systematic Assessment	EG0007 events5 affected76 at risk
DIARRHEA	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG00014 events11 affected76 at risk
DIZZINESS	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0009 events7 affected76 at risk
DRY MOUTH	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
DRY SKIN	Skin and subcutaneous tissue disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
DYSGEUSIA	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0009 events9 affected76 at risk
DYSPEPSIA	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
DYSPNEA	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG00024 events19 affected76 at risk
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY	Ear and labyrinth disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
EAR PAIN	Ear and labyrinth disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
EDEMA LIMBS	General disorders	CTCAEv4	Non-systematic Assessment	EG00012 events8 affected76 at risk
ENDOCRINE DISORDERS - OTHER, SPECIFY	Endocrine disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0004 events4 affected76 at risk
EYE DISORDERS - OTHER, SPECIFY	Eye disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
FACIAL PAIN	General disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
FALL	Injury, poisoning and procedural complications	CTCAEv4	Non-systematic Assessment	EG0005 events3 affected76 at risk
FATIGUE	General disorders	CTCAEv4	Non-systematic Assessment	EG00080 events54 affected76 at risk
FEVER	General disorders	CTCAEv4	Non-systematic Assessment	EG0005 events4 affected76 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
FLASHING LIGHTS	Eye disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
FLATULENCE	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
FLU LIKE SYMPTOMS	General disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
FLUSHING	Vascular disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
GAIT DISTURBANCE	General disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
GASTROESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0006 events5 affected76 at risk
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	General disorders	CTCAEv4	Non-systematic Assessment	EG0008 events6 affected76 at risk
GENERALIZED MUSCLE WEAKNESS	Musculoskeletal and connective tissue disorders	CTCAEv4	Non-systematic Assessment	EG0004 events3 affected76 at risk
GGT INCREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
HEADACHE	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG00012 events10 affected76 at risk
HEARING IMPAIRED	Ear and labyrinth disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
HEMATOMA	Vascular disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
HEMATURIA	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG00026 events19 affected76 at risk
HEMORRHOIDS	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
HEPATOBILIARY DISORDERS - OTHER, SPECIFY	Hepatobiliary disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
HICCUPS	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
HOARSENESS	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0003 events2 affected76 at risk
HYPERCALCEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
HYPERGLYCEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG00057 events32 affected76 at risk
HYPERKALEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG00012 events8 affected76 at risk
HYPERMAGNESEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
HYPERNATREMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
HYPERTENSION	Vascular disorders	CTCAEv4	Non-systematic Assessment	EG00028 events16 affected76 at risk
HYPERTHYROIDISM	Endocrine disorders	CTCAEv4	Non-systematic Assessment	EG0005 events3 affected76 at risk
HYPERTRIGLYCERIDEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
HYPERURICEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
HYPOALBUMINEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG00018 events12 affected76 at risk
HYPOCALCEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG00018 events11 affected76 at risk
HYPOGLYCEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG0005 events3 affected76 at risk
HYPOKALEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG00015 events12 affected76 at risk
HYPOMAGNESEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG00029 events14 affected76 at risk
HYPONATREMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG00047 events20 affected76 at risk
HYPOPHOSPHATEMIA	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG0006 events4 affected76 at risk
HYPOTENSION	Vascular disorders	CTCAEv4	Non-systematic Assessment	EG0005 events3 affected76 at risk
HYPOTHYROIDISM	Endocrine disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0003 events1 affected76 at risk
ILEUS	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
IMMUNE SYSTEM DISORDERS - OTHER, SPECIFY	Immune system disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
INFUSION RELATED REACTION	General disorders	CTCAEv4	Non-systematic Assessment	EG0004 events2 affected76 at risk
INFUSION SITE EXTRAVASATION	General disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
INJECTION SITE REACTION	General disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
INSOMNIA	Psychiatric disorders	CTCAEv4	Non-systematic Assessment	EG0009 events9 affected76 at risk
INVESTIGATIONS - OTHER, SPECIFY	Investigations	CTCAEv4	Non-systematic Assessment	EG0004 events3 affected76 at risk
KIDNEY INFECTION	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
LEFT VENTRICULAR SYSTOLIC DYSFUNCTION	Cardiac disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
LIBIDO DECREASED	Psychiatric disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
LIPASE INCREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG0009 events5 affected76 at risk
LOCALIZED EDEMA	General disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
LYMPHOCYTE COUNT DECREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG0004 events4 affected76 at risk
MEMORY IMPAIRMENT	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	Metabolism and nutrition disorders	CTCAEv4	Non-systematic Assessment	EG00017 events7 affected76 at risk
MUCOSITIS ORAL	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
MUSCLE WEAKNESS UPPER LIMB	Musculoskeletal and connective tissue disorders	CTCAEv4	Non-systematic Assessment	EG0002 events1 affected76 at risk
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	Musculoskeletal and connective tissue disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
NASAL CONGESTION	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
NAUSEA	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG00058 events43 affected76 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	CTCAEv4	Non-systematic Assessment	EG0002 events1 affected76 at risk
NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
NEURALGIA	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0002 events1 affected76 at risk
NEUTROPHIL COUNT DECREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG000151 events52 affected76 at risk
NON-CARDIAC CHEST PAIN	General disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
ORAL PAIN	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
PAIN	General disorders	CTCAEv4	Non-systematic Assessment	EG00013 events8 affected76 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	CTCAEv4	Non-systematic Assessment	EG0004 events4 affected76 at risk
PALPITATIONS	Cardiac disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
PAPULOPUSTULAR RASH	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
PARESTHESIA	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
PELVIC PAIN	Reproductive system and breast disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
PERINEAL PAIN	Reproductive system and breast disorders	CTCAEv4	Non-systematic Assessment	EG0004 events1 affected76 at risk
PERIORBITAL EDEMA	Skin and subcutaneous tissue disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
PERIORBITAL INFECTION	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
PERIPHERAL MOTOR NEUROPATHY	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0003 events1 affected76 at risk
PERIPHERAL SENSORY NEUROPATHY	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0006 events6 affected76 at risk
PHLEBITIS	Vascular disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
PHOTOSENSITIVITY	Skin and subcutaneous tissue disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
PLATELET COUNT DECREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG00059 events29 affected76 at risk
PRESYNCOPE	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
PROTEINURIA	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG00010 events9 affected76 at risk
PRURITUS	Skin and subcutaneous tissue disorders	CTCAEv4	Non-systematic Assessment	EG00013 events11 affected76 at risk
PSYCHIATRIC DISORDERS - OTHER, SPECIFY	Psychiatric disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
RASH ACNEIFORM	Skin and subcutaneous tissue disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
RASH MACULO-PAPULAR	Skin and subcutaneous tissue disorders	CTCAEv4	Non-systematic Assessment	EG00014 events13 affected76 at risk
RENAL AND URINARY DISORDERS - OTHER, SPECIFY	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG00026 events18 affected76 at risk
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
SEPSIS	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
SEROMA	Injury, poisoning and procedural complications	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
SERUM AMYLASE INCREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG00015 events7 affected76 at risk
SINUS DISORDER	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
SINUS TACHYCARDIA	Cardiac disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
SINUSITIS	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY	Skin and subcutaneous tissue disorders	CTCAEv4	Non-systematic Assessment	EG00013 events10 affected76 at risk
SOMNOLENCE	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
SORE THROAT	Respiratory, thoracic and mediastinal disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
STOMA SITE INFECTION	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
SUPERFICIAL THROMBOPHLEBITIS	Vascular disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
SURGICAL AND MEDICAL PROCEDURES - OTHER, SPECIFY	Surgical and medical procedures	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
SYNCOPE	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0003 events2 affected76 at risk
THROMBOEMBOLIC EVENT	Vascular disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
TINNITUS	Ear and labyrinth disorders	CTCAEv4	Non-systematic Assessment	EG00022 events21 affected76 at risk
TOOTHACHE	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG0003 events3 affected76 at risk
TREMOR	Nervous system disorders	CTCAEv4	Non-systematic Assessment	EG0005 events4 affected76 at risk
UPPER RESPIRATORY INFECTION	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
URINARY FREQUENCY	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG0007 events7 affected76 at risk
URINARY INCONTINENCE	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG0002 events2 affected76 at risk
URINARY RETENTION	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
URINARY TRACT INFECTION	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG00029 events15 affected76 at risk
URINARY TRACT PAIN	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG00012 events8 affected76 at risk
URINARY URGENCY	Renal and urinary disorders	CTCAEv4	Non-systematic Assessment	EG0004 events4 affected76 at risk
UROSTOMY LEAK	Injury, poisoning and procedural complications	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
VASCULAR DISORDERS - OTHER, SPECIFY	Vascular disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
VERTIGO	Ear and labyrinth disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
VESTIBULAR DISORDER	Ear and labyrinth disorders	CTCAEv4	Non-systematic Assessment	EG0001 events1 affected76 at risk
VOMITING	Gastrointestinal disorders	CTCAEv4	Non-systematic Assessment	EG00019 events14 affected76 at risk
WATERING EYES	Eye disorders	CTCAEv4	Non-systematic Assessment	EG0002 events1 affected76 at risk
WEIGHT GAIN	Investigations	CTCAEv4	Non-systematic Assessment	EG0004 events2 affected76 at risk
WEIGHT LOSS	Investigations	CTCAEv4	Non-systematic Assessment	EG00015 events10 affected76 at risk
WHITE BLOOD CELL DECREASED	Investigations	CTCAEv4	Non-systematic Assessment	EG00065 events31 affected76 at risk
WOUND INFECTION	Infections and infestations	CTCAEv4	Non-systematic Assessment	EG0002 events1 affected76 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
D000077594	Nivolumab
D000093542	Gemcitabine
D002945	Cisplatin

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins
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

Units	Counts
Participants	OG00032

Units	Counts
Participants	OG00033