Trial Outcomes & Findings for Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer (NCT NCT00093808)

Last Updated: 2017-03-06

Results Overview

A confirmed tumor response is defined to be either a Complete Response (CR) or Partial Response (PR) noted as the objective status on 2 consecutive evaluations at least 6 weeks apart. All patients meeting the eligibility criteria who have signed a consent form and initiated study medication will be evaluable for response. The proportion of confirmed tumor responses will be estimated by the number of tumor regressions that meet the RECIST criteria for a confirmed CR or PR divided by the total number of evaluable patients. A 95% confidence interval for the true confirmed response rate will be calculated using the properties of the binomial distribution. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

47 participants

Primary outcome timeframe

Up to 5 years

Results posted on

2017-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Capecitabine + Vinorelbine + Trastuzumab Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m\^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m\^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
Overall Study STARTED	47
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Capecitabine + Vinorelbine + Trastuzumab Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m\^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m\^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
Overall Study Cancel participation before receiving tx	1
Overall Study Protocol Violation	1

Baseline Characteristics

Capecitabine, Vinorelbine, and Trastuzumab in Treating Patients With Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Capecitabine + Vinorelbine + Trastuzumab n=46 Participants Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m\^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m\^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 5 years

Population: Patients who completed the study were included in all analyses unless otherwise specified.

Outcome measures

Outcome measures
Measure	Capecitabine + Vinorelbine + Trastuzumab n=45 Participants Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m\^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m\^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
Confirmed Response Rate	0.67 proportion of patients Interval 0.51 to 0.8

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.

Time to progression is defined as the time from registration to disease progression. Patients who died without documentation of progression will be considered to have progressed on the date of their death. If a patient starts treatment and fails to return for any evaluations, that patient will be censored for progression of disease at day one post-registration. Otherwise, for patients that do not progress, censoring will occur at the last follow up date. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Capecitabine + Vinorelbine + Trastuzumab n=46 Participants Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m\^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m\^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
Time to Progression (TTP)	11.3 months Interval 8.4 to 16.7

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.

Duration of response is defined for all eligible patients who have achieved an objective response as the date at which the patient's objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

Outcome measures

Outcome measures
Measure	Capecitabine + Vinorelbine + Trastuzumab n=46 Participants Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m\^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m\^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
Duration of Response as Measured by RECIST Criteria	13.2 months Interval 8.6 to 23.2

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patients who completed the study or deemed a protocol violation were included in all analyses unless otherwise specified.

Overall survival: The overall survival or survival time is defined as the time from registration to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Capecitabine + Vinorelbine + Trastuzumab n=46 Participants Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m\^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m\^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
Overall Survival as Assessed by Time	28.5 months Interval 24.8 to 36.4

Adverse Events

Capecitabine + Vinorelbine + Trastuzumab

Serious events: 9 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Capecitabine + Vinorelbine + Trastuzumab n=46 participants at risk Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m\^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m\^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
Blood and lymphatic system disorders Febrile neutropenia	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Cardiac disorders Cardiac disorder	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Diarrhea	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Upper gastrointestinal hemorrhage	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
General disorders Chest pain	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
General disorders Fatigue	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Neutrophil count decreased	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Platelet count decreased	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Metabolism and nutrition disorders Anorexia	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Metabolism and nutrition disorders Dehydration	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Metabolism and nutrition disorders Serum potassium increased	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Musculoskeletal and connective tissue disorders Bone pain	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).

Other adverse events

Other adverse events
Measure	Capecitabine + Vinorelbine + Trastuzumab n=46 participants at risk Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m\^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m\^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
Blood and lymphatic system disorders Hemoglobin decreased	23.9% 11/46 • Number of events 23 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Blood and lymphatic system disorders Hemolysis	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Cardiac disorders Cardiac disorder	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Cardiac disorders Left ventricular dysfunction	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Eye disorders Cataract	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Eye disorders Watering eyes	4.3% 2/46 • Number of events 9 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Abdominal pain	10.9% 5/46 • Number of events 9 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Constipation	10.9% 5/46 • Number of events 6 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Diarrhea	65.2% 30/46 • Number of events 113 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Dyspepsia	6.5% 3/46 • Number of events 4 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Ear, nose and throat examination abnormal	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Enteritis	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Esophagitis	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Gastrointestinal disorder	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Lower gastrointestinal hemorrhage	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Mucositis oral	17.4% 8/46 • Number of events 10 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Nausea	17.4% 8/46 • Number of events 9 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Toothache	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Gastrointestinal disorders Vomiting	10.9% 5/46 • Number of events 8 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
General disorders Chest pain	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
General disorders Edema limbs	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
General disorders Fatigue	97.8% 45/46 • Number of events 356 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
General disorders Fever	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
General disorders Injection site reaction	13.0% 6/46 • Number of events 19 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
General disorders Visceral edema	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Immune system disorders Cytokine release syndrome	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Immune system disorders Hypersensitivity	6.5% 3/46 • Number of events 3 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Infections and infestations Bladder infection	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Infections and infestations Infection	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Infections and infestations Lip infection	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Infections and infestations Nail infection	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Infections and infestations Pneumonia	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Infections and infestations Skin infection	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Infections and infestations Tooth infection	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Infections and infestations Upper respiratory infection	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Injury, poisoning and procedural complications Vascular access complication	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Alanine aminotransferase increased	2.2% 1/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Alkaline phosphatase increased	2.2% 1/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Aspartate aminotransferase increased	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Blood bilirubin increased	6.5% 3/46 • Number of events 5 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Creatinine increased	19.6% 9/46 • Number of events 13 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations INR increased	2.2% 1/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Leukocyte count decreased	23.9% 11/46 • Number of events 32 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Lipase increased	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Lymphocyte count decreased	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Neutrophil count decreased	84.8% 39/46 • Number of events 196 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Platelet count decreased	17.4% 8/46 • Number of events 38 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Investigations Weight loss	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Metabolism and nutrition disorders Anorexia	13.0% 6/46 • Number of events 8 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Metabolism and nutrition disorders Blood glucose increased	4.3% 2/46 • Number of events 7 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Metabolism and nutrition disorders Dehydration	8.7% 4/46 • Number of events 5 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Metabolism and nutrition disorders Serum calcium decreased	6.5% 3/46 • Number of events 5 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Metabolism and nutrition disorders Serum potassium decreased	8.7% 4/46 • Number of events 5 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Musculoskeletal and connective tissue disorders Arthralgia	8.7% 4/46 • Number of events 7 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Musculoskeletal and connective tissue disorders Back pain	6.5% 3/46 • Number of events 3 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Musculoskeletal and connective tissue disorders Bone pain	54.3% 25/46 • Number of events 136 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Musculoskeletal and connective tissue disorders Fibrosis	4.3% 2/46 • Number of events 8 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Musculoskeletal and connective tissue disorders Muscle weakness	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	2.2% 1/46 • Number of events 5 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Musculoskeletal and connective tissue disorders Myalgia	58.7% 27/46 • Number of events 139 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Nervous system disorders Dizziness	6.5% 3/46 • Number of events 3 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Nervous system disorders Dysgeusia	4.3% 2/46 • Number of events 8 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Nervous system disorders Headache	6.5% 3/46 • Number of events 7 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Nervous system disorders Neuralgia	2.2% 1/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Nervous system disorders Peripheral motor neuropathy	19.6% 9/46 • Number of events 23 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Nervous system disorders Peripheral sensory neuropathy	69.6% 32/46 • Number of events 298 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Nervous system disorders Syncope	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Psychiatric disorders Anxiety	2.2% 1/46 • Number of events 9 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Psychiatric disorders Depression	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Psychiatric disorders Insomnia	2.2% 1/46 • Number of events 12 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Renal and urinary disorders Proteinuria	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Reproductive system and breast disorders Vaginal pain	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	2.2% 1/46 • Number of events 6 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Respiratory, thoracic and mediastinal disorders Dyspnea	13.0% 6/46 • Number of events 20 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Respiratory, thoracic and mediastinal disorders Hypoxia	2.2% 1/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Skin and subcutaneous tissue disorders Alopecia	2.2% 1/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Skin and subcutaneous tissue disorders Dry skin	4.3% 2/46 • Number of events 3 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	54.3% 25/46 • Number of events 202 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Skin and subcutaneous tissue disorders Nail disorder	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Skin and subcutaneous tissue disorders Rash desquamating	23.9% 11/46 • Number of events 31 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Vascular disorders Hot flashes	2.2% 1/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Vascular disorders Hypotension	2.2% 1/46 • Number of events 1 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Vascular disorders Lymphedema	2.2% 1/46 • Number of events 3 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).
Vascular disorders Thrombosis	4.3% 2/46 • Number of events 2 • Adverse events are collected 2 weeks prior to registration, at each evaluation , and at end of treatment during the Active-Monitoring Phase; up to 5 years post registration. The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized until June 30, 2011. CTCAE version 4.0 will be utilized for expedited adverse event reporting only, beginning July 1, 2011. Adverse events data collected for patients who received and completed at least one cycle of treatment are reported below (i.e. for patients who completed the study or deemed a protocol violation).

Additional Information

Winston Tan, MD

Mayo Clinic

Phone: 904-953-7290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place