Trial Outcomes & Findings for Sapanisertib and Ziv-Aflibercept in Treating Patients With Recurrent Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery (NCT NCT02159989)

Last Updated: 2025-10-17

Results Overview

DLTs were defined as adverse events per Common Terminology Criteria for Adverse Events version 4.0, related to study agents and fulfilling one of the following criteria: Hematologic * Grade 4 neutropenia for \> 7 days * Febrile neutropenia (defined as absolute neutrophil count \[ANC\] \< 1.0 x 109/L and fever ≥ 38.5° C) or grade ≥3 infection with ANC≤1.0 x 109/L. * Platelet count \< 25,000/mm for \> 7 days Non-hematologic * Any toxicity ≥grade 3 that persists for \> 7 days, except: 1. nausea/vomiting, diarrhea and electrolyte imbalances; 2. grade 3 lab abnormalities that are asymptomatic and responsive to supportive measures and that are without clinical consequence; and 3. grade 3 hyperglycemia or grade 3 diabetes that can be stably controlled. * Delay of treatment \> 7 days due to hematologic and \> 14 days due to non-hematologic toxicity MTD is the highest dose level at which no more than 1 of 6 evaluable patients had a DLT

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

83 participants

Primary outcome timeframe

DLT was assessed during Cycle 1 (28-day cycle).

Results posted on

2025-10-17

Participant Flow

This is an open label, Phase I trial examining MLN0128 in Combination with Ziv-Aflibercept in patients with advanced cancers at The University of Texas MD Anderson Cancer Center.

Of the 83 patients, only 55 patients received at least 1 dose of the study agents. The remaining 28 patients screen failed and did not receive any dose of the study drugs. Per the protocol, all 55 patients who received one or more doses of drug were included in the analysis and the results are reported here.

Participant milestones

Participant milestones
Measure	Dose Level 1 MLN0128 (mg PO): 3 QD Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 1b MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2 MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 3 MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4 MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5 MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 6 MLN0128 (mg PO): 6 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5a MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4a MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2a: MTD Dose MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 2a Expansion MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3
Overall Study STARTED	5	4	3	3	4	3	7	4	3	9	10
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	5	4	3	3	4	3	7	4	3	9	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1 MLN0128 (mg PO): 3 QD Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 1b MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2 MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 3 MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4 MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5 MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 6 MLN0128 (mg PO): 6 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5a MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4a MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2a: MTD Dose MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 2a Expansion MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3
Overall Study Adverse Event	1	0	0	0	1	0	1	2	0	2	1
Overall Study Death	0	0	0	0	0	0	0	0	0	0	1
Overall Study Lack of Efficacy	2	3	3	0	2	3	3	1	3	6	7
Overall Study Lost to Follow-up	0	0	0	1	0	0	0	0	0	0	1
Overall Study Withdrawal by Subject	2	0	0	2	1	0	3	1	0	0	0
Overall Study New treatment	0	1	0	0	0	0	0	0	0	0	0
Overall Study Insurance Issues	0	0	0	0	0	0	0	0	0	1	0

Baseline Characteristics

Sapanisertib and Ziv-Aflibercept in Treating Patients With Recurrent Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 n=5 Participants MLN0128 (mg PO): 3 QD Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 1b n=4 Participants MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2 n=3 Participants MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 3 n=3 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4 n=4 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5 n=3 Participants MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 6 n=7 Participants MLN0128 (mg PO): 6 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5a n=4 Participants MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4a n=3 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2a n=9 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 2a Expansion n=10 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Total n=55 Participants Total of all reporting groups
Age, Categorical <=18 years	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	1 Participants n=42 Participants	8 Participants n=42 Participants	7 Participants n=42 Participants	35 Participants n=42 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	4 Participants n=8 Participants	2 Participants n=24 Participants	2 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	20 Participants n=42 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	2 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	7 Participants n=42 Participants	7 Participants n=42 Participants	40 Participants n=42 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=8 Participants	5 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	15 Participants n=42 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	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	5 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	5 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	7 Participants n=42 Participants	9 Participants n=42 Participants	43 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	7 Participants n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	6 Participants n=8 Participants	2 Participants n=24 Participants	3 Participants n=42 Participants	7 Participants n=42 Participants	8 Participants n=42 Participants	46 Participants n=42 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=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 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	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	2 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	6 Participants n=42 Participants
Region of Enrollment United States	5 participants n=5 Participants	4 participants n=7 Participants	3 participants n=5 Participants	3 participants n=4 Participants	4 participants n=21 Participants	3 participants n=8 Participants	7 participants n=8 Participants	4 participants n=24 Participants	3 participants n=42 Participants	9 participants n=42 Participants	10 participants n=42 Participants	55 participants n=42 Participants

PRIMARY outcome

Timeframe: DLT was assessed during Cycle 1 (28-day cycle).

Population: Patients enrolled in the dose escalation phase must have received at least 75% of planned doses of both drugs to be evaluable for a DLT.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=5 Participants MLN0128 (mg PO): 3 QD Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 1b n=4 Participants MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2 n=3 Participants MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 3 n=3 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4 n=4 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5 n=3 Participants MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 6 n=7 Participants MLN0128 (mg PO): 6 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5a n=4 Participants MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4a n=3 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2a n=9 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 2a Expansion n=10 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3
Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At baseline and every 8 weeks. Confirmatory scans done 8 (not less than 4) weeks following initial documentation of objective response. If a patient has been on the study for 12 months, the response was evaluated every 12 weeks, assessed up to 3 years.

Population: Only those patients who had measurable disease present at baseline, had received at least one cycle of therapy, and have had their disease re-evaluated were considered evaluable for response

Tumor response by change in tumor size from baseline assessed by Objective response rate was defined as the percentage of patients who had complete response (CR) or partial response (PR) according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=4 Participants MLN0128 (mg PO): 3 QD Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 1b n=3 Participants MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2 n=3 Participants MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 3 n=3 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4 n=4 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5 n=3 Participants MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 6 n=7 Participants MLN0128 (mg PO): 6 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5a n=3 Participants MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4a n=3 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2a n=8 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 2a Expansion n=9 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3
Tumor Response by Change in Tumor Size From Baseline: Objective Response Rate Per RECIST v1.1	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Tumor response by change in tumor size from baseline assessed by Disease control rate was defined as the percentage of patients who had CR or PR or stable disease (SD) according to RECIST v1.1.

Outcome measures

Outcome measures
Measure	Dose Level 1 n=4 Participants MLN0128 (mg PO): 3 QD Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 1b n=3 Participants MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2 n=3 Participants MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 3 n=3 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4 n=4 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5 n=3 Participants MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 6 n=7 Participants MLN0128 (mg PO): 6 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5a n=3 Participants MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4a n=3 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2a n=8 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 2a Expansion n=9 Participants MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3
Tumor Response by Change in Tumor Size From Baseline: Disease Control Rate Per RECIST v1.1	2 Participants	3 Participants	3 Participants	3 Participants	4 Participants	2 Participants	4 Participants	2 Participants	3 Participants	7 Participants	6 Participants

Deaths: 7 deaths

Dose Level 2a Expansion

Serious events: 2 serious events

Other events: 10 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1 n=5 participants at risk MLN0128 (mg PO): 3 QD Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 1b n=4 participants at risk MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2 n=3 participants at risk MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 3 n=3 participants at risk MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4 n=4 participants at risk MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5 n=3 participants at risk MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 6 n=7 participants at risk MLN0128 (mg PO): 6 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5a n=4 participants at risk MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4a n=3 participants at risk MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2a n=9 participants at risk MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 2a Expansion n=10 participants at risk MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3
Gastrointestinal disorders Abdominal pain	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Blood and lymphatic system disorders Anemia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Anorexia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Ascites	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Aspiration	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Blood bilirubin increased	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Creatinine increased	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Diarrhea	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Nervous system disorders Dysphasia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Esophagitis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
General disorders Fever	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Gastritis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Hepatobiliary disorders Hepatobiliary disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Vascular disorders Hypertension	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypocalcemia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypokalemia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Lipase increased	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Infections and infestations Lung infection	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
General disorders Pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Pancreatitis	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Infections and infestations Papulopustular rash	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Cardiac disorders Pericardial effusion	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Platelet count decreased	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Skin and subcutaneous tissue disorders Pruritus	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Skin and subcutaneous tissue disorders Rash maculo-papular	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Vascular disorders Thromboembolic event	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Nervous system disorders Transient ischemic attacks	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Renal and urinary disorders Urinary tract infection	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Reproductive system and breast disorders Vaginal bleeding	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Vomiting	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.

Other adverse events

Other adverse events
Measure	Dose Level 1 n=5 participants at risk MLN0128 (mg PO): 3 QD Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 1b n=4 participants at risk MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2 n=3 participants at risk MLN0128 (mg PO): 3 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 3 n=3 participants at risk MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4 n=4 participants at risk MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5 n=3 participants at risk MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 6 n=7 participants at risk MLN0128 (mg PO): 6 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 4	Dose Level 5a n=4 participants at risk MLN0128 (mg PO): 5 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 4a n=3 participants at risk MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 2	Dose Level 2a n=9 participants at risk MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3	Dose Level 2a Expansion n=10 participants at risk MLN0128 (mg PO): 4 (3 days on/4 days off) Ziv-Aflibercept (mg/kg IV Q2 weeks): 3
Gastrointestinal disorders Abdominal pain	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	75.0% 3/4 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	44.4% 4/9 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 3/9 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Endocrine disorders Adrenal insufficiency	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Alanine aminotransferase increased	60.0% 3/5 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	42.9% 3/7 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 3/9 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 5/10 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 5/10 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Alkaline phosphatase increased	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	71.4% 5/7 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	55.6% 5/9 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	60.0% 6/10 • Number of events 6 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Blood and lymphatic system disorders Anemia	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 4/4 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	57.1% 4/7 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 4/4 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 6/9 • Number of events 6 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	60.0% 6/10 • Number of events 6 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Anorexia	80.0% 4/5 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	57.1% 4/7 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Psychiatric disorders Anxiety	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 3/9 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Infections and infestations Appendicitis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Arthralgia	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Ascites	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Aspartate aminotransferase increased	60.0% 3/5 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	71.4% 5/7 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 3/9 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	60.0% 6/10 • Number of events 6 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Bloating	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Blood bilirubin increased	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	28.6% 2/7 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Eye disorders Blurred vision	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Cardiac disorders Cardiac disorders - Other	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Cardiac disorders Chest pain - cardiac	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Cholesterol high	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	55.6% 5/9 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	60.0% 6/10 • Number of events 6 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Eye disorders Conjunctivitis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Constipation	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	42.9% 3/7 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 5/10 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 3/9 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Creatinine increased	60.0% 3/5 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	57.1% 4/7 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 3/9 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	40.0% 4/10 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Dehydration	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Psychiatric disorders Depression	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Injury, poisoning and procedural complications Dermatitis radiation	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Diarrhea	60.0% 3/5 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	75.0% 3/4 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	42.9% 3/7 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Eye disorders Dry eye	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Dry mouth	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Nervous system disorders Dysgeusia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Dysphagia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	75.0% 3/4 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	42.9% 3/7 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	75.0% 3/4 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	55.6% 5/9 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Ear and labyrinth disorders Ear pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Endocrine disorders Endocrine disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Esophageal pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Eye disorders Eye disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Eye disorders Eye pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
General disorders Fatigue	100.0% 5/5 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 4/4 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 4/4 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	85.7% 6/7 • Number of events 6 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 4/4 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 9/9 • Number of events 9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	80.0% 8/10 • Number of events 8 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
General disorders Fever	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
General disorders Gait disturbance	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Gastritis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	42.9% 3/7 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Gastrointestinal disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	40.0% 4/10 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
General disorders General disorders and administration site conditions - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Nervous system disorders Headache	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	28.6% 2/7 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Ear and labyrinth disorders Hearing impaired	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Renal and urinary disorders Hematuria	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Hemoglobin increased	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Hemorrhoids	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Hepatobiliary disorders Hepatobiliary disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Hoarseness	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Vascular disorders Hot flashes	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypercalcemia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hyperglycemia	60.0% 3/5 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	57.1% 4/7 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	88.9% 8/9 • Number of events 8 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	80.0% 8/10 • Number of events 8 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hyperkalemia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Hyperlipidemia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	28.6% 2/7 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	28.6% 2/7 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Hyperphosphatemia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Vascular disorders Hypertension	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	75.0% 3/4 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	57.1% 4/7 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	55.6% 5/9 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Endocrine disorders Hyperthyroidism	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypertriglyceridemia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	71.4% 5/7 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	55.6% 5/9 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	60.0% 6/10 • Number of events 6 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hyperuricemia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypoalbuminemia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 3/9 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypocalcemia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	44.4% 4/9 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypomagnesemia	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	75.0% 3/4 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	42.9% 3/7 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hyponatremia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	44.4% 4/9 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Hypophosphatemia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Endocrine disorders Hypothyroidism	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Immune system disorders Immune system disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Infections and infestations Infections and infestations - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations INR increased	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	40.0% 4/10 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Psychiatric disorders Insomnia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Investigations - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Lipase increased	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	28.6% 2/7 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 3/9 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 5/10 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Vascular disorders Lymphedema	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Lymphocyte count decreased	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 3/9 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Mucositis oral	80.0% 4/5 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	75.0% 3/4 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	57.1% 4/7 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	40.0% 4/10 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	60.0% 6/10 • Number of events 6 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	75.0% 3/4 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	57.1% 4/7 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	55.6% 5/9 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	40.0% 4/10 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	28.6% 2/7 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Nervous system disorders Nervous system disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	28.6% 2/7 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Neutrophil count decreased	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Oral dysesthesia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Oral pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
General disorders Pain	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Cardiac disorders Palpitations	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Nervous system disorders Paresthesia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Cardiac disorders Pericardial effusion	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	28.6% 2/7 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	44.4% 4/9 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 5/10 • Number of events 5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Nervous system disorders Peripheral sensory neuropathy	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Infections and infestations pharyngitis	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Platelet count decreased	40.0% 2/5 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	50.0% 2/4 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	42.9% 3/7 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Pleural effusion	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Renal and urinary disorders Proteinuria	60.0% 3/5 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 3/9 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Vascular disorders Pulmonary embolism	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Skin and subcutaneous tissue disorders Rash acneiform	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Skin and subcutaneous tissue disorders Rash maculo-papular	60.0% 3/5 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Renal and urinary disorders Renal and urinary disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Reproductive system and breast disorders Reproductive system and breast disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	20.0% 2/10 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Serum amylase increased	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	28.6% 2/7 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Sinus disorder	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Sinusitis	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Cardiac disorders Sinus tachycardia	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	28.6% 2/7 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	30.0% 3/10 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Sleep apnea	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Cardiac disorders Tachycardia	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Vascular disorders Thromboembolic event	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Infections and infestations Thrush	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Ear and labyrinth disorders Tinnitus	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Nervous system disorders Tremor	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Renal and urinary disorders Urinary retention	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Renal and urinary disorders Urinary tract infection	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Renal and urinary disorders Urinary tract pain	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Renal and urinary disorders Urinary urgency	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	11.1% 1/9 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Skin and subcutaneous tissue disorders Urticaria	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	33.3% 1/3 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Vascular disorders Vascular disorders - Other	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	10.0% 1/10 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Gastrointestinal disorders Vomiting	20.0% 1/5 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	66.7% 2/3 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	44.4% 4/9 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations Weight loss	80.0% 4/5 • Number of events 4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/7 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/9 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.
Investigations White blood cell decreased	0.00% 0/5 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	25.0% 1/4 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	14.3% 1/7 • Number of events 1 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/4 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	100.0% 3/3 • Number of events 3 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	22.2% 2/9 • Number of events 2 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.	0.00% 0/10 • Patients were monitored for AE from the first day of administration of study medication through 30 days (+/- 7 days) of discontinuation of study drug. In addition, for patients who experience significant toxicities on study, follow-up continued until toxicities resolved through study completion an average of 2 years. All AEs were reported to regulatory authorities, NCI, and investigators in accordance with all applicable regulations. AEs were graded per NCI CTCAE v4.0. Serious Adverse Events and Serious unexpected problems were reported per standard IRB reporting requirements.

Additional Information

Aung Naing

MD Anderson Cancer Center

Phone: 713-563-3885

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60