Trial Outcomes & Findings for Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma (NCT NCT01535924)

Last Updated: 2021-11-19

Results Overview

Dose limiting toxicity will be defined during cycle 1 only of the phase I trial. Hematologic and Infectious Dose Limiting Toxicities include: Grade 3 febrile neutropenia persisting\> 7 days, Grade 4 infection or febrile neutropenia. Treatment delay\>14 days due to grade 3-4 neutropenia or thrombocytopenia. Non-Hematological Dose Limiting Toxicities include: any Grade 3 or 4 non-hematologic toxicity related to study treatment with the exception of nausea or vomiting, alopecia, or electrolyte/glucose abnormalities that are correctable within 72 hours.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

26 participants

Primary outcome timeframe

up to 5 years

Results posted on

2021-11-19

Participant Flow

The current study was conducted at the Ohio State University in Columbus, Ohio, and Emory University in Atlanta, Georgia.

Participant milestones

Participant milestones
Measure	Phase 1 (Dose Level 1) Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Level 2) Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Level 3) Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Level 4) Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 2 (Dose Level 5) Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.	Phase 2 Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
Overall Study STARTED	3	3	3	4	6	7
Overall Study COMPLETED	3	3	3	4	6	7
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gemcitabine and Bendamustine in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1 (Dose Levels 1) n=3 Participants Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV	Phase 1 (Dose Levels 2) n=3 Participants Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Levels 3) n=3 Participants Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Levels 4) n=4 Participants Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 2 (Dose Levels 5) n=6 Participants Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.	Phase 2 n=7 Participants Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.	Total n=26 Participants Total of all reporting groups
Age, Continuous	38 years STANDARD_DEVIATION 17.34 • n=5 Participants	38 years STANDARD_DEVIATION 9.16 • n=7 Participants	35 years STANDARD_DEVIATION 11.63 • n=5 Participants	50 years STANDARD_DEVIATION 7.78 • n=4 Participants	33.33 years STANDARD_DEVIATION 16.05 • n=21 Participants	37.14 years STANDARD_DEVIATION 12.03 • n=10 Participants	38.19 years STANDARD_DEVIATION 12.82 • n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=10 Participants	10 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	5 Participants n=10 Participants	16 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=10 Participants	25 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	6 Participants n=10 Participants	21 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	3 patients n=5 Participants	3 patients n=7 Participants	3 patients n=5 Participants	4 patients n=4 Participants	6 patients n=21 Participants	7 patients n=10 Participants	26 patients n=115 Participants

PRIMARY outcome

Timeframe: up to 5 years

Population: Only patients in Phase I analyzed

Outcome measures

Outcome measures
Measure	Phase 1 (Dose Levels 1) n=3 Participants Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV	Phase 1 (Dose Levels 2) n=3 Participants Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Levels 3) n=3 Participants Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Levels 4) n=4 Participants Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 2 (Dose Levels 5) Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.	Phase 2 Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
Adverse Events in Terms of Dose-limiting Toxicity (DLT) and MTD of Bendamustine Hydrochloride (Phase I)	0 number of patients	0 number of patients	0 number of patients	0 number of patients	—	—

SECONDARY outcome

Timeframe: up to 5 years

Population: Only patients in Phase II analyzed

Tested using Simon's two-stage Minimax design. Descriptive statistics (i.e. means, standard deviations, 95% confidence intervals for continuous variables, and frequencies for discrete data) and graphical analyses will be used for all correlative laboratory parameters. The associations between correlative laboratory parameters and clinical response will be evaluated using two sample t test or Fisher's exact test, whichever is appropriate.

Outcome measures

Outcome measures
Measure	Phase 1 (Dose Levels 1) Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV	Phase 1 (Dose Levels 2) Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Levels 3) Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Levels 4) Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 2 (Dose Levels 5) n=6 Participants Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.	Phase 2 n=7 Participants Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
Overall Response Rate (ORR) of Bendamustine Hydrochloride and Gemcitabine Hydrochloride in Patients With Relapsed or Refractory Hodgkin Lymphoma (Phase II)	—	—	—	—	67 percentage of patients	71 percentage of patients

Adverse Events

Phase 1 (Dose Levels 1)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 (Dose Levels 2)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 (Dose Levels 3)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1 (Dose Levels 4)

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 2 (Dose Levels 5)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Phase 2

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1 (Dose Levels 1) n=3 participants at risk Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV	Phase 1 (Dose Levels 2) n=3 participants at risk Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Levels 3) n=3 participants at risk Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Levels 4) n=4 participants at risk Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 2 (Dose Levels 5) n=6 participants at risk Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.	Phase 2 n=7 participants at risk Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
Immune system disorders Immune Systems Disorder	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Infections and infestations Infection and Infestations	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Renal and urinary disorders Intraoperative urinary injury	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Infections and infestations Lung infection	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Vascular disorders Thromboembolic event	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Renal and urinary disorders Chronic Kidney Disease	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Eye disorders Eye Pain	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
General disorders Fever	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Vascular disorders Hypotension	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Other adverse events

Other adverse events
Measure	Phase 1 (Dose Levels 1) n=3 participants at risk Dose Level 1: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 60 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. gemcitabine hydrochloride: Given IV bendamustine hydrochloride: Given IV	Phase 1 (Dose Levels 2) n=3 participants at risk Dose Level 2: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Levels 3) n=3 participants at risk Dose Level 3: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 120 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 1 (Dose Levels 4) n=4 participants at risk Dose Level 4: Patients receive Gemcitabine 1000 mg/m2 IV over 30 minutes on day 1 and Bendamustine 90 mg/m2 IV over 30 minutes on days 1 and 2. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.	Phase 2 (Dose Levels 5) n=6 participants at risk Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.	Phase 2 n=7 participants at risk Patients receive Gemcitabine 1000mg/m2 on day 1 and Bendamustine 120mg/m2 on days 1 and 2 of each 21 day cycle. Gemcitabine shall be administered prior to Bendamustine on day 1 of each cycle.
Gastrointestinal disorders Abdominal Pain	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	28.6% 2/7 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 2/4 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 3/6 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	28.6% 2/7 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Investigations Alkaline phosphatase increased	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 2/4 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 4/6 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	71.4% 5/7 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Blood and lymphatic system disorders Anemia	66.7% 2/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 3/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 2/4 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 6/6 • Number of events 7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 7/7 • Number of events 9 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Metabolism and nutrition disorders Anorexia	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Psychiatric disorders Anxiety	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	42.9% 3/7 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	28.6% 2/7 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Infections and infestations Bronchial infection	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
General disorders Chills	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Renal and urinary disorders Chronic kidney disease	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Gastrointestinal disorders Constipation	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	28.6% 2/7 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 2/6 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	42.9% 3/7 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Investigations Creatinine increased	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Immune system disorders Cytokine release syndrome	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Psychiatric disorders Depression	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Gastrointestinal disorders Diarrhea	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 2/4 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Nervous system disorders Dizziness	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
General disorders Edema face	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
General disorders Edema limbs	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Eye disorders Eye disorders - Other, specify	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Musculoskeletal and connective tissue disorders Fall	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
General disorders Fatigue	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	57.1% 4/7 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
General disorders Fever	100.0% 3/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	75.0% 3/4 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Vascular disorders Flushing	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Nervous system disorders Headache	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 2/4 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 2/6 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	42.9% 3/7 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Vascular disorders Hematoma	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Gastrointestinal disorders Hemorrhoids	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Metabolism and nutrition disorders Hyperglycemia	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	75.0% 3/4 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 2/6 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	42.9% 3/7 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 3/6 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 3/6 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	42.9% 3/7 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Psychiatric disorders Insomnia	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	57.1% 4/7 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Infections and infestations Lung infection	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Investigations Lymphocyte count decreased	100.0% 3/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 3/3 • Number of events 9 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 3/3 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 4/4 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 6/6 • Number of events 7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 7/7 • Number of events 10 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 3/3 • Number of events 11 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 4/4 • Number of events 6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 4/6 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	71.4% 5/7 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Investigations Neutrophil count decreased	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 2/4 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Cardiac disorders Palpitations	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Blood and lymphatic system disorders Platelet count decreased	66.7% 2/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 4/4 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 3/6 • Number of events 6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	57.1% 4/7 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 2/6 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	42.9% 3/7 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Infections and infestations Sinusitis	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Infections and infestations Upper respiratory infection	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	14.3% 1/7 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Renal and urinary disorders Urinary tract pain	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Vascular disorders Vascular disorders - Other, specify	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	42.9% 3/7 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 2/4 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 3/6 • Number of events 6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	28.6% 2/7 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Investigations White blood cell decreased	66.7% 2/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	100.0% 3/3 • Number of events 5 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	16.7% 1/6 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	42.9% 3/7 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 1/3 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Eye disorders Blurred vision	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	25.0% 1/4 • Number of events 1 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/6 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/7 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	66.7% 2/3 • Number of events 3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	0.00% 0/3 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	50.0% 2/4 • Number of events 4 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	33.3% 2/6 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0	28.6% 2/7 • Number of events 2 • The Adverse event information was collected for study patients from baseline through study completion utilizing the CTCAE version 4.0 to determine the severity of the reaction for adverse event reporting from baseline to after study completion, up to 5 years. The National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Additional Information

Dr. Beth Christian

The Ohio State University

Phone: 614-293-7807

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place