Trial Outcomes & Findings for PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer (NCT NCT00088413)

NCT ID: NCT00088413

Last Updated: 2019-04-16

Results Overview

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all clinical and laboratory signs and symptoms of disease for a minimum of 4 weeks during which no new lesions may appear. Partial Response is a minimum of 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable disease is neither sufficient shrinkage to qualify for partial response nor progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: Approximately 6 months while on trial
• Results posted on: 2019-04-16

Participant Flow

Participant milestones

Measure	Colorectal Cancer Cohort Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (\>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.	Non-Colorectal Cancer Cohort Patients with histologically confirmed measurable or evaluable metastatic non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (\>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.	Breast Cohort Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.	Ovarian Cohort Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Overall Study STARTED	10	15	12	14
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	10	15	12	14

Reasons for withdrawal

Measure	Colorectal Cancer Cohort Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (\>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.	Non-Colorectal Cancer Cohort Patients with histologically confirmed measurable or evaluable metastatic non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (\>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.	Breast Cohort Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.	Ovarian Cohort Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Overall Study Limited supply of trmt drug (PANVAC-f)	0	0	1	0
Overall Study Adverse Events/Side Effects	0	1	1	0
Overall Study Refused trmt Off-study per pt wishes	0	1	1	0
Overall Study Off study due to missing a vaccine dose	1	0	0	0
Overall Study Death	0	1	0	0
Overall Study Progressive disease	9	11	8	14
Overall Study Other	0	1	0	0
Overall Study Patient unevaluable due to adverse event	0	0	1	0

Baseline Characteristics

PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer

Baseline characteristics by cohort

Measure	Colorectal Cancer Cohort n=10 Participants Patients with histologically confirmed measurable or evaluable colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (\>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.	Non-Colorectal Cancer Cohort n=15 Participants Patients with histologically confirmed measurable or evaluable metastatic non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (\>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.	Breast Cohort n=12 Participants Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.	Ovarian Cohort n=14 Participants Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.	Total n=51 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
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	12 Participants n=4 Participants	42 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Age, Continuous	52.4 years STANDARD_DEVIATION 12.2 • n=5 Participants	57.6 years STANDARD_DEVIATION 7.91 • n=7 Participants	56.5 years STANDARD_DEVIATION 11.8 • n=5 Participants	54.8 years STANDARD_DEVIATION 9.0 • n=4 Participants	55.6 years STANDARD_DEVIATION 10.0 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	13 Participants n=7 Participants	12 Participants n=5 Participants	14 Participants n=4 Participants	43 Participants n=21 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	8 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	9 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	14 Participants n=4 Participants	50 Participants n=21 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized Black or African-American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race/Ethnicity, Customized White	10 Participants n=5 Participants	12 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	22 Participants n=21 Participants
Race/Ethnicity, Customized Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region of Enrollment United States	10 Participants n=5 Participants	15 Participants n=7 Participants	12 Participants n=5 Participants	14 Participants n=4 Participants	51 Participants n=21 Participants
Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0-1 Grade 0	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	16 Participants n=21 Participants
Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0-1 Grade 1	6 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	35 Participants n=21 Participants
Number of Participants with Prior Therapy No prior chemotherapy	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Number of Participants with Prior Therapy Chemotherapy (1 regimen)	2 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Number of Participants with Prior Therapy Chemotherapy (2 regimens)	3 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	12 Participants n=21 Participants
Number of Participants with Prior Therapy Chemotherapy (≥3 regimens)	5 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	12 Participants n=4 Participants	29 Participants n=21 Participants
Number of Participants with Prior Therapy Radiation	2 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants	0 Participants n=4 Participants	13 Participants n=21 Participants
Number of Participants with a Primary Tumor Colorectal	10 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants
Number of Participants with a Primary Tumor Gastric	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Number of Participants with a Primary Tumor Pancreatic	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Number of Participants with a Primary Tumor Appendiceal	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Number of Participants with a Primary Tumor Esophageal adenocarcinoma	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Number of Participants with a Primary Tumor Ovarian	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	14 Participants n=4 Participants	17 Participants n=21 Participants
Number of Participants with a Primary Tumor Breast	0 Participants n=5 Participants	2 Participants n=7 Participants	12 Participants n=5 Participants	0 Participants n=4 Participants	14 Participants n=21 Participants
Number of Participants with a Primary Tumor Lung	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: Approximately 6 months while on trial

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all clinical and laboratory signs and symptoms of disease for a minimum of 4 weeks during which no new lesions may appear. Partial Response is a minimum of 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable disease is neither sufficient shrinkage to qualify for partial response nor progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.

Outcome measures

Measure	Breast Cancer Cohort n=12 Participants Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.	Ovarian Cancer Cohort n=14 Participants Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts Complete Response	1 Participants	0 Participants
Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts Partial Response	0 Participants	0 Participants
Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts Stable Disease	4 Participants	3 Participants
Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts Progressive Disease	7 Participants	11 Participants

PRIMARY outcome

Timeframe: Approximately 6 months while on trial

Population: The colorectal and non-colorectal cohorts received the same treatment on the same schedule, had no immune dysfunction at baseline and are biologically equivalent. For rare events in small cohorts, a better estimate of the true event rate is determined by grouping similar patients and is consistent with the peer-reviewed clinical paper.

Grade 1 (mild) and Grade 2 (moderate) adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	Breast Cancer Cohort n=180 Vaccines administered Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.	Ovarian Cancer Cohort Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group Injection-site reaction	88 Percentage of vaccines	—
Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group Fatigue	5 Percentage of vaccines	—
Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group Fever	3 Percentage of vaccines	—
Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group Hemoglobin/Anemia	1 Percentage of vaccines	—
Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group Hypoalbuminemia	1 Percentage of vaccines	—
Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group Alk Phos	1 Percentage of vaccines	—
Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group Syncope	0 Percentage of vaccines	—
Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group Anorexia	1 Percentage of vaccines	—
Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group Vomiting	1 Percentage of vaccines	—
Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group Hot flushes/flashes	1 Percentage of vaccines	—

SECONDARY outcome

Timeframe: Approximately 2 months while on trial

Population: The breast and ovarian cohorts received the same treatment on the same schedule, had no evidence of immune dysfunction at baseline and are biologically equivalent. For rare events that occur in small trial arms, the true event rate is better determined by grouping similar patients and is consistent with the peer-reviewed clinical paper.

Vaccines were administered to participants and Grade 1 (mild) and Grade 2 (moderate) adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. Common Terminology Criteria in Adverse Events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	Breast Cancer Cohort n=26 Participants Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.	Ovarian Cancer Cohort Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Percentage of Participants With Grade 1 and Grade 2 Adverse Events Possibly, Likely, or Definitely Related to Vaccine in the Breast Cancer and Ovarian Cancer Cohorts Injection-site reaction	22 percentage of participants	—
Percentage of Participants With Grade 1 and Grade 2 Adverse Events Possibly, Likely, or Definitely Related to Vaccine in the Breast Cancer and Ovarian Cancer Cohorts Musculoskeletal pain	2 percentage of participants	—
Percentage of Participants With Grade 1 and Grade 2 Adverse Events Possibly, Likely, or Definitely Related to Vaccine in the Breast Cancer and Ovarian Cancer Cohorts Anemia	1 percentage of participants	—

SECONDARY outcome

Timeframe: Date consent signed to date off study, approximately 164 months and 10 days

Population: Pts in these 2 cohorts rec'd the same treatment, have absence of immune dysfunction at baseline and are biologically equivalent. For rare events that occur in small cohorts, a better est. of the true event rate can be determined by grouping the pts in the absence of a biological rationale and is consistent with the peer-reviewed clinical paper.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Measure	Breast Cancer Cohort n=25 Participants Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.	Ovarian Cancer Cohort n=26 Participants Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 and v4.0	25 Participants	26 Participants

SECONDARY outcome

Timeframe: post vaccination (up to Day 84)

Population: Overall number of participants analyzed reflects participants that are HLA-A2 positive.

Immune response in human leukocyte antigens (HLA)-A2 positive patients to carcinoembryonic antigen (CEA) was assessed by enzyme-linked immunospot assay (ELISPOT) analysis. A positive immune response was defined as a >2x fold increase in the number of interferon gamma producing cells.

Outcome measures

Measure	Breast Cancer Cohort n=9 Participants Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.	Ovarian Cancer Cohort n=9 Participants Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Colorectal Cancer and Non-colorectal Cancer Cohort Post Vaccination	3 Participants	6 Participants

SECONDARY outcome

Timeframe: post vaccination (up to Day 84)

Population: Only 3 Breast Cancer and 2 Ovarian Cancer patients had enough blood collected to perform enzyme-linked immunospot (ELISPOT) analysis.

Immune response in human leukocyte antigens (HLA)-A2 positive patients to carcinoembryonic antigen (CEA) was assessed by enzyme-linked immunospot assay (ELISPOT) analysis. A positive immune response was defined as a >2x fold increase in the number of interferon gamma producing cells.

Outcome measures

Measure	Breast Cancer Cohort n=3 Participants Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.	Ovarian Cancer Cohort n=2 Participants Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.
Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Breast Cancer and Ovarian Cancer Cohorts Post Vaccination	1 Participants	1 Participants

Adverse Events

Colorectal Cancer vs Non-Colorectal Cancer Cohort

Serious events: 25 serious events

Other events: 25 other events

Deaths: 1 deaths

Breast and Ovarian Cohorts

Serious events: 26 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Colorectal Cancer vs Non-Colorectal Cancer Cohort n=25 participants at risk Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (\>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.	Breast and Ovarian Cohorts n=26 participants at risk Patients with evaluable, metastatic breast or ovarian cancer who have failed or not a candidate for standard therapy.
Nervous system disorders Headache*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Urinary NOS*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders HEMORRHAGE/BLEEDING:: Hemorrhage/Bleeding - Other (Spotting)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Psychiatric disorders Hallucinations*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Activated partial thromboplastin time prolonged*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Alanine aminotransferase increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Alkaline phosphatase increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Immune system disorders Allergic reaction*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders Anemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Aspartate aminotransferase increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders BLOOD/BONE MARROW:: Hemoglobin*3	52.0% 13/25 • Number of events 34 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	30.8% 8/26 • Number of events 14 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders BLOOD/BONE MARROW:: Leukocytes (total WBC)*3	16.0% 4/25 • Number of events 22 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders BLOOD/BONE MARROW:: Lymphopenia*3	8.0% 2/25 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)*3	20.0% 5/25 • Number of events 13 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders BLOOD/BONE MARROW:: Platelets*3	12.0% 3/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders Back pain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Injury, poisoning and procedural complications Bruising*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Cardiac disorders CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Weight gain*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations CPK increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Creatinine increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders Cystitis noninfective*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Allergic reaction-Tape)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Dry skin*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes*3	100.0% 25/25 • Number of events 146 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	88.5% 23/26 • Number of events 83 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Psychiatric disorders Delirium*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Psychiatric disorders Depression*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders Diarrhea*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Injury, poisoning and procedural complications Fall*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders Fever*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Anorexia*3	20.0% 5/25 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Constipation*3	12.0% 3/25 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Dehydration*3	16.0% 4/25 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Diarrhea*3	20.0% 5/25 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Distension/bloating, abdominal*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Dysphagia (difficulty swallowing)*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Heartburn/dyspepsia*3	24.0% 6/25 • Number of events 12 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Nausea*3	20.0% 5/25 • Number of events 12 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	38.5% 10/26 • Number of events 13 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Vomiting*3	20.0% 5/25 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders Gingival pain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hyperglycemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypernatremia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hyperuricemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypoalbuminemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypocalcemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypoglycemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypokalemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypomagnesemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hyponatremia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypophosphatemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection - Other (Lt. lower leg, redness, swelling, & whelts)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Lung (pneumonia)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders Injection site reaction*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Investigations - Other, specify*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders LYMPHATICS:: Edema: limb*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Lipase increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Lymphocyte count decreased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Hemoglobinuria*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Sodium, serum-high (hypernatremia)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL/SOFT TISSUE:: Muscle weakness, generalized or specific area	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	11.5% 3/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Mood alteration:: Agitation*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Neuropathy: motor*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders Nasal congestion*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders Neck pain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders Nervous system disorders - Other, specify*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Neutrophil count decreased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders Non-cardiac chest pain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Burning sensation waist & tumor area)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Chest/thorax NOS*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Reproductive system and breast disorders PAIN:: Pain:: Pelvis*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	11.5% 3/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders PAIN:: Pain:: Throat/pharynx/larynx*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders PULMONARY/UPPER RESPIRATORY:: Nasal cavity/paranasal sinus reactions*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders PULMONARY/UPPER RESPIRATORY:: Pleural effusion (non-malignant)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders Pain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders Peripheral motor neuropathy*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders Pleural effusion*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders Pruritus*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders SYNDROMES:: Flu-like syndrome*3	12.0% 3/25 • Number of events 12 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	69.2% 18/26 • Number of events 35 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Cardiac disorders Sinus bradycardia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Surgical and medical procedures Surgical and medical procedures - Other, specify*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders Vomiting*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Weight gain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Injury, poisoning and procedural complications Wound dehiscence*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations Wound infection*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Immune system disorders ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)*3	8.0% 2/25 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	15.4% 4/26 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Cardiac disorders CARDIAC ARRHYTHMIA:: Palpitations*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Cardiac disorders CARDIAC GENERAL:: Hypotension*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders COAGULATION:: INR (International Normalized Ratio of prothrombin time)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders COAGULATION:: PTT (Partial Thromboplastin Time)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Constitutional Symptoms - Other (Cold )*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)*3	52.0% 13/25 • Number of events 24 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	38.5% 10/26 • Number of events 20 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia,	40.0% 10/25 • Number of events 14 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	50.0% 13/26 • Number of events 18 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Insomnia*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Rigors/chills*3	48.0% 12/25 • Number of events 14 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	11.5% 3/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)*3	16.0% 4/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Weight loss*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders DEATH:: Death not associated with CTCAE term:: Disease progression NOS*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Bruising (in absence of Grade 3 or 4 thrombocytopenia)*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Induration/fibrosis (skin and subcutaneous tissue)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Nail changes*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Pruritus/itching*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Rash/desquamation*3	8.0% 2/25 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Endocrine disorders ENDOCRINE:: Hot flashes/flushes*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Endocrine disorders ENDOCRINE:: Thyroid function, low (hypothyroidism)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Flatulence*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Gastrointestinal - Other (Partial bowel obstruction)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Oral cavity*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Obstruction, GI:: Small bowel NOS*3	4.0% 1/25 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Taste alteration (dysgeusia)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Lower GI NOS*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Rectum*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Bladder*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Hepatobiliary disorders HEPATOBILIARY/PANCREAS:: Pancreatitis*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection with unknown ANC:: Urinary tract NOS*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection with unknown ANC:: Wound*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders LYMPHATICS:: Lymphatics - Other (Edema-Left ankle)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)*3	32.0% 8/25 • Number of events 18 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)*3	28.0% 7/25 • Number of events 12 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	30.8% 8/26 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3	60.0% 15/25 • Number of events 26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	76.9% 20/26 • Number of events 25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Alkaline phosphatase*3	32.0% 8/25 • Number of events 10 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Amylase*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Bicarbonate, serum-low*3	8.0% 2/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)*3	32.0% 8/25 • Number of events 12 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	11.5% 3/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: CPK (creatine phosphokinase)*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)*3	20.0% 5/25 • Number of events 7 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)*3	20.0% 5/25 • Number of events 7 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Cholesterol, serum-high (hypercholesteremia)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Creatinine*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: GGT (gamma-Glutamyl transpeptidase)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)*3	36.0% 9/25 • Number of events 11 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Lipase*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)*3	12.0% 3/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)*3	16.0% 4/25 • Number of events 11 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)*3	8.0% 2/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)*3	8.0% 2/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Proteinuria*3	16.0% 4/25 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)*3	28.0% 7/25 • Number of events 10 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	15.4% 4/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)*3	20.0% 5/25 • Number of events 14 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Dizziness*3	20.0% 5/25 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Mood alteration:: Anxiety*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Mood alteration:: Depression*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Neuropathy: cranial:: CN I Smell*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Neuropathy: cranial:: CN VIII Hearing and balance*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Syncope (fainting)*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Eye disorders OCULAR/VISUAL:: Keratitis (corneal inflammation/corneal ulceration)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Eye disorders OCULAR/VISUAL:: Vision-blurred vision*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders PAIN:: Pain:: Abdomen NOS*3	20.0% 5/25 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	23.1% 6/26 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Back*3	40.0% 10/25 • Number of events 11 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders PAIN:: Pain:: Bladder*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Bone*3	12.0% 3/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Chest wall*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Extremity-limb*3	24.0% 6/25 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	15.4% 4/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Eye disorders PAIN:: Pain:: Eye*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders PAIN:: Pain:: Head/headache*3	48.0% 12/25 • Number of events 20 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	42.3% 11/26 • Number of events 17 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Joint*3	16.0% 4/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Muscle*3	48.0% 12/25 • Number of events 20 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	15.4% 4/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Neck*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders PAIN:: Pain:: Oral cavity*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain:: Pain NOS*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders PAIN:: Pain:: Stomach*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders PULMONARY/UPPER RESPIRATORY:: Bronchospasm, wheezing*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders PULMONARY/UPPER RESPIRATORY:: Cough*3	20.0% 5/25 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	26.9% 7/26 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders RENAL/GENITOURINARY:: Bladder spasms*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders RENAL/GENITOURINARY:: Renal/Genitourinary - Other (Dysuria)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders RENAL/GENITOURINARY:: Urinary frequency/urgency*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders Dermatology/Skin - Other (Mouth sore-lower lip)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Gastrointestinal - Other (Emesis)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Gastrointestinal - Other (Erythema Mucosa-Under tongue & hard palate)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Gastrointestinal - Other (Gastroesophageal reflux disease )*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Right inguinal pain)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Rt. thigh pain)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Sternum pain)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Pain-Upper right quadrant)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Rt. flank)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Rt. ear)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Pain from inserted biliary stents)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.

Other adverse events

Measure	Colorectal Cancer vs Non-Colorectal Cancer Cohort n=25 participants at risk Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (\>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.	Breast and Ovarian Cohorts n=26 participants at risk Patients with evaluable, metastatic breast or ovarian cancer who have failed or not a candidate for standard therapy.
Immune system disorders ALLERGY/IMMUNOLOGY:: Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)*3	8.0% 2/25 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Activated partial thromboplastin time prolonged*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	15.4% 4/26 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Alanine aminotransferase increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Alkaline phosphatase increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Immune system disorders Allergic reaction*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders Anemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Aspartate aminotransferase increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders BLOOD/BONE MARROW:: Hemoglobin*3	52.0% 13/25 • Number of events 34 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders BLOOD/BONE MARROW:: Leukocytes (total WBC)*3	16.0% 4/25 • Number of events 22 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	30.8% 8/26 • Number of events 14 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders BLOOD/BONE MARROW:: Lymphopenia*3	8.0% 2/25 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders BLOOD/BONE MARROW:: Neutrophils/granulocytes (ANC/AGC)*3	20.0% 5/25 • Number of events 13 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders BLOOD/BONE MARROW:: Platelets*3	12.0% 3/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders Back pain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Injury, poisoning and procedural complications Bruising*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Cardiac disorders CARDIAC ARRHYTHMIA:: Supraventricular and nodal arrhythmia:: Sinus tachycardia*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Fatigue (asthenia, lethargy, malaise)*3	52.0% 13/25 • Number of events 24 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	38.5% 10/26 • Number of events 20 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Insomnia*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	50.0% 13/26 • Number of events 18 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Rigors/chills*3	48.0% 12/25 • Number of events 14 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Sweating (diaphoresis)*3	16.0% 4/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	11.5% 3/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Weight gain*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations CPK increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Creatinine increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders Cystitis noninfective*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Allergic reaction-Tape )*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Dry skin*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Injection site reaction/extravasation changes*3	100.0% 25/25 • Number of events 146 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Pruritus/itching*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	88.5% 23/26 • Number of events 83 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Rash/desquamation*3	8.0% 2/25 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Psychiatric disorders Delirium*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Psychiatric disorders Depression*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders Diarrhea*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Injury, poisoning and procedural complications Fall*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders Fever*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Anorexia*3	20.0% 5/25 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Constipation*3	12.0% 3/25 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Diarrhea*3	20.0% 5/25 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Distension/bloating, abdominal*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Dysphagia (difficulty swallowing)*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Heartburn/dyspepsia*3	24.0% 6/25 • Number of events 12 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	15.4% 4/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Nausea*3	20.0% 5/25 • Number of events 12 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Vomiting*3	20.0% 5/25 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	38.5% 10/26 • Number of events 13 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders Gingival pain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Urinary NOS*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders HEMORRHAGE/BLEEDING:: Hemorrhage/Bleeding - Other (Spotting )*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Psychiatric disorders Hallucinations*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders Headache*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hyperglycemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hyperuricemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypoalbuminemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypoglycemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypomagnesemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders Hypophosphatemia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection - Other (Lt. lower leg, redness, swelling & whelts)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Lung (pneumonia)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Urinary tract NOS*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders Injection site reaction*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders LYMPHATICS:: Edema: limb*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations Lipase increased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Lymphocyte count decreased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: ALT, SGPT (serum glutamic pyruvic transaminase)*3	32.0% 8/25 • Number of events 18 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: AST, SGOT(serum glutamic oxaloacetic transaminase)*3	28.0% 7/25 • Number of events 12 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Albumin, serum-low (hypoalbuminemia)*3	60.0% 15/25 • Number of events 26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	30.8% 8/26 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Alkaline phosphatase*3	32.0% 8/25 • Number of events 10 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	76.9% 20/26 • Number of events 25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Bilirubin (hyperbilirubinemia)*3	32.0% 8/25 • Number of events 12 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: CPK (creatine phosphokinase)*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	11.5% 3/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Calcium, serum-high (hypercalcemia)*3	20.0% 5/25 • Number of events 7 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Calcium, serum-low (hypocalcemia)*3	12.0% 3/25 • Number of events 7 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Cholesterol, serum-high (hypercholesteremia)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Glucose, serum-high (hyperglycemia)*3	36.0% 9/25 • Number of events 11 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Glucose, serum-low (hypoglycemia)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Hemoglobinuria*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Magnesium, serum-high (hypermagnesemia)*3	12.0% 3/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Magnesium, serum-low (hypomagnesemia)*3	16.0% 4/25 • Number of events 11 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Phosphate, serum-low (hypophosphatemia)*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Potassium, serum-high (hyperkalemia)*3	8.0% 2/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Potassium, serum-low (hypokalemia)*3	8.0% 2/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Proteinuria*3	16.0% 4/25 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Sodium, serum-high (hypernatremia)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Sodium, serum-low (hyponatremia)*3	28.0% 7/25 • Number of events 10 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Uric acid, serum-high (hyperuricemia)*3	20.0% 5/25 • Number of events 14 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	15.4% 4/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders MUSCULOSKELETAL/SOFT TISSUE	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Dizziness*3	20.0% 5/25 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	11.5% 3/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Mood alteration:: Agitation*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Mood alteration:: Depression*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Neuropathy: motor*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders Nasal congestion*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders Neck pain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders Nervous system disorders - Other, specify*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Neutrophil count decreased*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders Non-cardiac chest pain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Burning sensation waist & tumor area)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders PAIN:: Pain:: Abdomen NOS*3	20.0% 5/25 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	11.5% 3/26 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Back*3	40.0% 10/25 • Number of events 11 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	23.1% 6/26 • Number of events 8 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Bone*3	12.0% 3/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	19.2% 5/26 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Chest wall*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	7.7% 2/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Chest/thorax NOS*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Extremity-limb*3	24.0% 6/25 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Eye disorders PAIN:: Pain:: Eye*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	15.4% 4/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders PAIN:: Pain:: Head/headache*3	48.0% 12/25 • Number of events 20 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Muscle*3	48.0% 12/25 • Number of events 20 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	42.3% 11/26 • Number of events 17 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Reproductive system and breast disorders PAIN:: Pain:: Pelvis*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	15.4% 4/26 • Number of events 4 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders PAIN:: Pain:: Stomach*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	11.5% 3/26 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders PAIN:: Pain:: Throat/pharynx/larynx*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders PULMONARY/UPPER RESPIRATORY:: Cough*3	20.0% 5/25 • Number of events 6 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders PULMONARY/UPPER RESPIRATORY:: Dyspnea (shortness of breath)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	26.9% 7/26 • Number of events 9 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders PULMONARY/UPPER RESPIRATORY:: Nasal cavity/paranasal sinus reactions*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders Pain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders Peripheral motor neuropathy*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders Pruritus*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders RENAL/GENITOURINARY:: Urinary frequency/urgency*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders SYNDROMES:: Flu-like syndrome*3	12.0% 3/25 • Number of events 12 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Cardiac disorders Sinus bradycardia*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	69.2% 18/26 • Number of events 35 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders Vomiting*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Investigations Weight gain*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Injury, poisoning and procedural complications Wound dehiscence*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations Wound infection*4	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Eye disorders Eye disorders - Other, specify	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Cardiac disorders CARDIAC ARRHYTHMIA:: Palpitations*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Cardiac disorders CARDIAC GENERAL:: Hypotension*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders COAGULATION:: INR (International Normalized Ratio of prothrombin time)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders COAGULATION:: PTT (Partial Thromboplastin Time)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Constitutional Symptoms - Other (Cold)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Fever (in the absence of neutropenia, where neutropenia is defined as ANC	40.0% 10/25 • Number of events 14 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders CONSTITUTIONAL SYMPTOMS:: Weight loss*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Bruising (in absence of Grade 3 or 4 thrombocytopenia)*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Induration/fibrosis (skin and subcutaneous tissue)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Nail changes*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Endocrine disorders ENDOCRINE:: Hot flashes/flushes*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Endocrine disorders ENDOCRINE:: Thyroid function, low (hypothyroidism)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Dehydration*3	12.0% 3/25 • Number of events 3 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Flatulence*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Mucositis/stomatitis (functional/symptomatic):: Oral cavity*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Obstruction, GI:: Small bowel NOS*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Taste alteration (dysgeusia)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Lower GI NOS*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders HEMORRHAGE/BLEEDING:: Hemorrhage, GI:: Rectum*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders HEMORRHAGE/BLEEDING:: Hemorrhage, GU:: Bladder*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders HEMORRHAGE/BLEEDING:: Hemorrhage, pulmonary/upper respiratory:: Nose*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection with normal ANC or Grade 1 or 2 neutrophils:: Sinus*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Infections and infestations INFECTION:: Infection with unknown ANC:: Urinary tract NOS*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Blood and lymphatic system disorders LYMPHATICS:: Lymphatics - Other (Edema-left ankle)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Amylase*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Bicarbonate, serum-low*3	8.0% 2/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Creatinine*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: GGT (gamma-Glutamyl transpeptidase)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Metabolism and nutrition disorders METABOLIC/LABORATORY:: Lipase*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Mood alteration:: Anxiety*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Neuropathy: cranial:: CN I Smell*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Neuropathy: cranial:: CN VIII Hearing and balance*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Nervous system disorders NEUROLOGY:: Syncope (fainting)*3	8.0% 2/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Eye disorders OCULAR/VISUAL:: Keratitis (corneal inflammation/corneal ulceration)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Eye disorders OCULAR/VISUAL:: Vision-blurred vision*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Pain-upper right quadrant)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders PAIN:: Pain:: Bladder*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain:: Joint*3	16.0% 4/25 • Number of events 5 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Musculoskeletal and connective tissue disorders PAIN:: Pain:: Neck*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders PAIN:: Pain:: Oral cavity*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain:: Pain NOS*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Respiratory, thoracic and mediastinal disorders PULMONARY/UPPER RESPIRATORY:: Bronchospasm, wheezing*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders RENAL/GENITOURINARY:: Bladder spasms*3	4.0% 1/25 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Renal and urinary disorders RENAL/GENITOURINARY:: Renal/Genitourinary - Other (Dysuria)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Skin and subcutaneous tissue disorders DERMATOLOGY/SKIN:: Dermatology/Skin - Other (Mouth sore-lower lip)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Gastrointestinal - Other (Emesis)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Gastrointestinal - Other (Erythema mucosa-under tongue & hard palate )*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Gastrointestinal - Other (Gastroesophageal reflux disease)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
Gastrointestinal disorders GASTROINTESTINAL:: Gastrointestinal - Other (Partial bowel obstruction)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Right inguinal pain)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Rt. thigh pain)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 2 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Sternum pain)*3	0.00% 0/25 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	3.8% 1/26 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Rt. flank)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Rt. ear)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.
General disorders PAIN:: Pain - Other (Pain from inserted biliary stents)*3	4.0% 1/25 • Number of events 1 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.	0.00% 0/26 • Date treatment consent signed to date off study, approximately 164 months and 10 days. Adverse events were assessed by the Common Terminology Criteria in Adverse Events(CTCAE)\*v3.0 if reported prior to August 1, 2010 and CTCAE \*v4.0 if reported after.

Additional Information

Dr. James Gulley

National Cancer Institute

Phone: 301-480-8870

Email: james_gulley@nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place