Trial Outcomes & Findings for Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme (NCT NCT00621686)

Last Updated: 2018-05-08

Results Overview

Primary Endpoint: 6-month progression free survival (PFS6): The proportion of successes will be estimated using the binomial point estimator (number of successes divided by the total number of evaluable patients) and the binomial 95% confidence interval estimated. To be classified as a success, an evaluable patient must be alive and progression-free 6 months after registration to the study. Patients who die prior to 6 months after study registration will be considered to have failed. Progression is defined as a \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

54 participants

Primary outcome timeframe

at 6 months

Results posted on

2018-05-08

Participant Flow

Participant milestones

Participant milestones
Measure	Sorafenib + Bevacizumab/Group A Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.	Sorafenib + Bevacizumab /Group B Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
Overall Study STARTED	19	35
Overall Study COMPLETED	19	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sorafenib + Bevacizumab/Group A n=19 Participants Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.	Sorafenib + Bevacizumab /Group B n=35 Participants Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.	Total n=54 Participants Total of all reporting groups
Age, Continuous	54 years n=5 Participants	55 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	12 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	23 Participants n=7 Participants	35 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	35 participants n=7 Participants	54 participants n=5 Participants

PRIMARY outcome

Timeframe: at 6 months

Outcome measures

Outcome measures
Measure	Sorafenib + Bevacizumab/Group A n=19 Participants Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.	Sorafenib + Bevacizumab /Group B n=35 Participants Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
6-month Progression-free Survival	0.263 proportion of participants Interval 0.101 to 0.514	0.171 proportion of participants Interval 0.072 to 0.343

SECONDARY outcome

Timeframe: Time from study registration to a) date of disease progression, or b) last follow-up; Up to 15 years

Time to progression (TTP) is defined to be the length of time from study registration to a) date of disease progression as defined by section 11.0 of the protocol, or b) last follow-up. If a patient dies without documentation of disease progression, the patient will be considered to have had a tumor progression at the time of death unless there is sufficient documented evidence to conclude no progression occurred prior to death. Time to progression curves were compared via the log-rank test. Progression is defined as a \>25% increase in product of perpendicular diameters of contrast enhancement or mass or appearance of new lesions or unequivocal increase in size of contrast enhancement or increase in mass effect as agreed upon independently by primary physician and quality control physicians: appearance of new lesions compared to pretreatment MRI and/or CT scan.

Outcome measures

Outcome measures
Measure	Sorafenib + Bevacizumab/Group A n=19 Participants Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.	Sorafenib + Bevacizumab /Group B n=35 Participants Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
Time to Progression	3.61 months Interval 1.84 to 5.95	2.66 months Interval 2.07 to 3.25

SECONDARY outcome

Timeframe: Time from date of registration to a) date of death due to any cause or b) last follow-up; Up to 15 years

Overall survival (OS) is defined as the length of time from date of registration to a) date of death due to any cause or b) last follow-up.

Outcome measures

Outcome measures
Measure	Sorafenib + Bevacizumab/Group A n=19 Participants Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.	Sorafenib + Bevacizumab /Group B n=35 Participants Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
Overall Survival	5.58 months Interval 4.11 to 8.48	5.62 months Interval 3.22 to 8.67

Adverse Events

Sorafenib + Bevacizumab/Group A

Serious events: 9 serious events

Other events: 19 other events

Deaths: 0 deaths

Sorafenib + Bevacizumab /Group B

Serious events: 9 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Evanthia Galanis, M.D.

Mayo Clinic

Phone: 507/284-3559

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Sorafenib + Bevacizumab/Group A n=19 participants at risk Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.	Sorafenib + Bevacizumab /Group B n=35 participants at risk Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
Blood and lymphatic system disorders Hemoglobin decreased	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Eye disorders Photophobia	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Abdominal pain	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	5.7% 2/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Constipation	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Diarrhea	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Nausea	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Pancreatitis	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
General disorders Chest pain	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
General disorders Disease progression	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	5.7% 2/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
General disorders Fatigue	10.5% 2/19 • Number of events 3 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	8.6% 3/35 • Number of events 4 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
General disorders Fever	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	5.7% 2/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Abdominal infection	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Anorectal infection	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Infection	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Pneumonia	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Alanine aminotransferase increased	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Amylase increased	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Platelet count decreased	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Weight loss	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Metabolism and nutrition disorders Anorexia	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	5.7% 2/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Metabolism and nutrition disorders Blood glucose increased	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Metabolism and nutrition disorders Dehydration	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Metabolism and nutrition disorders Serum calcium decreased	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Metabolism and nutrition disorders Serum phosphate decreased	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Musculoskeletal and connective tissue disorders Muscle weakness	10.5% 2/19 • Number of events 3 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Musculoskeletal and connective tissue disorders Pain in extremity	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Nervous system disorders Ataxia	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Nervous system disorders Depressed level of consciousness	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Nervous system disorders Dizziness	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Nervous system disorders Headache	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	5.7% 2/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Nervous system disorders Mini mental status examination abnormal	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Nervous system disorders Seizure	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Nervous system disorders Speech disorder	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Psychiatric disorders Anxiety	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Psychiatric disorders Confusion	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	5.7% 2/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Renal and urinary disorders Glomerular filtration rate decreased	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Renal and urinary disorders Urinary incontinence	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	5.7% 2/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.

Other adverse events
Measure	Sorafenib + Bevacizumab/Group A n=19 participants at risk Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.	Sorafenib + Bevacizumab /Group B n=35 participants at risk Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
Blood and lymphatic system disorders Hemoglobin decreased	42.1% 8/19 • Number of events 25 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	45.7% 16/35 • Number of events 26 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Cardiac disorders Ventricular tachycardia	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Eye disorders Cataract	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Eye disorders Optic nerve disorder	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Eye disorders Vision blurred	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Abdominal pain	21.1% 4/19 • Number of events 6 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	14.3% 5/35 • Number of events 7 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Diarrhea	47.4% 9/19 • Number of events 22 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	31.4% 11/35 • Number of events 24 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Dry mouth	5.3% 1/19 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Dysphagia	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Ear, nose and throat examination abnormal	36.8% 7/19 • Number of events 11 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	22.9% 8/35 • Number of events 20 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Flatulence	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Mucositis oral	26.3% 5/19 • Number of events 6 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	22.9% 8/35 • Number of events 18 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Nausea	36.8% 7/19 • Number of events 15 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	37.1% 13/35 • Number of events 22 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Oral pain	5.3% 1/19 • Number of events 3 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Pancreatitis	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Gastrointestinal disorders Vomiting	15.8% 3/19 • Number of events 5 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	14.3% 5/35 • Number of events 6 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
General disorders Disease progression	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
General disorders Edema limbs	5.3% 1/19 • Number of events 3 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
General disorders Fatigue	94.7% 18/19 • Number of events 118 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	97.1% 34/35 • Number of events 220 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
General disorders Fever	10.5% 2/19 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
General disorders Pain	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Abdominal infection	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Bronchitis	5.3% 1/19 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Infectious colitis	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Pharyngitis	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Pneumonia	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Sinusitis	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Skin infection	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Stoma site infection	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Infections and infestations Upper aerodigestive tract infection	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	8.6% 3/35 • Number of events 6 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Alanine aminotransferase increased	10.5% 2/19 • Number of events 3 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	5.7% 2/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Aspartate aminotransferase increased	0.00% 0/19 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 2 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Bilirubin increased	5.3% 1/19 • Number of events 1 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	0.00% 0/35 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Leukocyte count decreased	21.1% 4/19 • Number of events 10 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	25.7% 9/35 • Number of events 14 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Lipase increased	15.8% 3/19 • Number of events 3 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	8.6% 3/35 • Number of events 5 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Lymphocyte count decreased	15.8% 3/19 • Number of events 6 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	37.1% 13/35 • Number of events 29 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Neutrophil count decreased	10.5% 2/19 • Number of events 3 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	2.9% 1/35 • Number of events 3 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Platelet count decreased	52.6% 10/19 • Number of events 52 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	48.6% 17/35 • Number of events 31 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.
Investigations Weight loss	26.3% 5/19 • Number of events 39 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.	28.6% 10/35 • Number of events 30 • Adverse event assessments were collected ≤21 days prior to registration, prior to each new treatment cycle, at PD, withdrawal, or removal, and 28-42 days after treatment discontinuation; for up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. The CTCAE v3.0 can be accessed from the CTEP home page http://ctep.cancer.gov.