Trial Outcomes & Findings for Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer (NCT NCT00662129)

NCT ID: NCT00662129

Last Updated: 2017-04-17

Results Overview

The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: at 6 months
• Results posted on: 2017-04-17

Participant Flow

Participant milestones

Measure	Paclitaxel + Gemcitabine + Bevacizumab Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	50
Overall Study COMPLETED	47
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Paclitaxel + Gemcitabine + Bevacizumab Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study Protocol Violation	1
Overall Study Cancel prior to beginning treatment	1
Overall Study Ineligible	1

Baseline Characteristics

Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

Baseline characteristics by cohort

Measure	Paclitaxel + Gemcitabine + Bevacizumab n=48 Participants Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	55.5 years n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	48 participants n=5 Participants

PRIMARY outcome

Timeframe: at 6 months

Population: The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.

The primary endpoint of this trial is the 6-month progression-free survival rate. A patient is considered to be a 6-month progression-free survivor if the patient is 6 months from registration without a documentation of disease progression (note, the patient need not be on study treatment at 6 months to be considered a success). The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the properties of the binomial distribution. Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

Outcome measures

Measure	Paclitaxel + Gemcitabine + Bevacizumab n=48 Participants Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
6-month Progression-free Survival (PFS) Rate	0.792 proportion of patients progression-free Interval 0.647 to 0.882

SECONDARY outcome

Timeframe: Up to 5 years

Population: The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.

Overall Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier (1958).

Outcome measures

Measure	Paclitaxel + Gemcitabine + Bevacizumab n=48 Participants Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Survival Time	24.4 months Interval 18.2 to 29.3

SECONDARY outcome

Timeframe: Up to 5 years

Population: The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.

Progression-free survival time is defined as the time from registration to the earliest date of documentation of disease progression. If a patient dies without a documentation of disease progression the patient will be considered to have had disease progression at the time of their death. The distribution of time to progression will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

Outcome measures

Measure	Paclitaxel + Gemcitabine + Bevacizumab n=48 Participants Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
PFS Time	11.2 months Interval 8.7 to 13.8

SECONDARY outcome

Timeframe: Up to 5 years

Population: The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.

A confirmed 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 8 weeks apart. The confirmed response rate (percentage) will be estimated by the number of confirmed responses in evaluable patients divided by the total number of evaluable patients multiplied by 100. The appropriate confidence interval will be calculated based on the binomial distribution.

Outcome measures

Measure	Paclitaxel + Gemcitabine + Bevacizumab n=48 Participants Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Confirmed Response (Complete or Partial Response) Rate	70.8 percentage of patients with CR or PR Interval 55.9 to 83.1

SECONDARY outcome

Timeframe: Up to 5 years

Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented. If a patient dies subsequent to the confirmed response without a documentation of disease progression, the patient will be considered to have had disease progression at the time of their death. In the case of a patient failing to return for evaluations before a documentation of disease progression, the patient will be censored for progression on the date of last evaluation. The distribution of duration of response will be estimated using the method of Kaplan-Meier (1958).

Outcome measures

Measure	Paclitaxel + Gemcitabine + Bevacizumab n=34 Participants Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Duration of Response	9.7 months Interval 5.9 to 14.7

SECONDARY outcome

Timeframe: Up to 5 years

Population: The ineligible patient was included in the final analysis with participants who completed the study as specified in the Participant Flow.

Time to treatment failure is defined to be the time from the date of registration to the date at which the patient is removed from treatment due to progression, adverse events, or refusal. If the patient is considered to be a major treatment violation or is taken off study as a non-protocol failure, the patient will be censored on the date they were removed from treatment. The distribution of time to treatment failure will be estimated using the method of Kaplan-Meier (1958). Progression is defined using the RECIST Criteria, as at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

Outcome measures

Measure	Paclitaxel + Gemcitabine + Bevacizumab n=48 Participants Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Time to Treatment Failure	6.9 months Interval 5.2 to 8.5

SECONDARY outcome

Timeframe: From baseline to end of Cycle 8; Up to 24 weeks

Population: Of the participants evaluable for primary analysis, the Overall Number of Participants Analyzed reflects the number of subjects evaluable for this secondary outcome (with a FACT-B Trial Outcome Index score at baseline and at Cycle 8).

Quality of life (QOL) as measured by the mean change (from baseline) in FACT-B (TOI) Trial Outcome Index at Cycle 8 (24 weeks). FACT-B was scored according to the published scoring (*) criteria with higher scores representing better QOL. The FACT-B TOI was the sum of the following FACT-B subscale/scale scores: physical (score range 0-28), functional (score range 0-28), and Breast Cancer Subscale (score range 0-40); range of the FACT-B TOI is 0-96 (the change scores have a possible range of -96 to 96). The mean change and 95% confidence interval are reported below. A one-sample t-test is used to compare the change from baseline to a value of 0.

(*)= Brady MJ, Cella DF, Mo F, Bonomi AE, Tulsky DS, Lloyd SR, Deasy S, Cobleigh M, Shiomoto G. Reliability and validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) quality of life instrument. J Clin Oncol 1997;15:974-986.

Outcome measures

Measure	Paclitaxel + Gemcitabine + Bevacizumab n=27 Participants Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Quality of Life, as Measure by the Mean Change in FACT-B TOI Score at Cycle 8	-7.4 units on a scale Interval -12.1 to -2.8

Adverse Events

Paclitaxel + Gemcitabine + Bevacizumab

Serious events: 20 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	Paclitaxel + Gemcitabine + Bevacizumab n=49 participants at risk Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Febrile neutropenia	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Blood and lymphatic system disorders Hemoglobin decreased	6.1% 3/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Constipation	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Diarrhea	6.1% 3/49 • Number of events 4 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Mucositis oral	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Nausea	6.1% 3/49 • Number of events 4 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Oral cavity fistula	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Vomiting	4.1% 2/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
General disorders Fatigue	6.1% 3/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
General disorders Fever	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Catheter related infection	2.0% 1/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Infection	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Urinary tract infection	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Alanine aminotransferase increased	2.0% 1/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Amylase increased	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Aspartate aminotransferase increased	2.0% 1/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Bilirubin increased	2.0% 1/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Leukocyte count decreased	8.2% 4/49 • Number of events 6 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Lipase increased	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Neutrophil count decreased	20.4% 10/49 • Number of events 13 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Platelet count decreased	10.2% 5/49 • Number of events 5 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Metabolism and nutrition disorders Anorexia	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Metabolism and nutrition disorders Dehydration	4.1% 2/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Metabolism and nutrition disorders Serum calcium decreased	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Musculoskeletal and connective tissue disorders Bone pain	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Musculoskeletal and connective tissue disorders Joint pain	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Musculoskeletal and connective tissue disorders Muscle weakness	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Musculoskeletal and connective tissue disorders Myalgia	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Nervous system disorders Dizziness	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Renal and urinary disorders Protein urine positive	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Renal and urinary disorders Renal failure	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Dyspnea	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	6.1% 3/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Alopecia	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Vascular disorders Thrombosis	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).

Other adverse events

Measure	Paclitaxel + Gemcitabine + Bevacizumab n=49 participants at risk Patients receive 125 mg/m\^2 paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and 1000 mg/m\^2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8, and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Febrile neutropenia	4.1% 2/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Blood and lymphatic system disorders Hemoglobin decreased	85.7% 42/49 • Number of events 308 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Cardiac disorders Atrial fibrillation	2.0% 1/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Cardiac disorders Atrial flutter	4.1% 2/49 • Number of events 5 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Cardiac disorders Myocardial ischemia	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Eye disorders Cataract	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Eye disorders Eye disorder	2.0% 1/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Eye disorders Vision blurred	6.1% 3/49 • Number of events 4 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Abdominal pain	6.1% 3/49 • Number of events 4 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Constipation	22.4% 11/49 • Number of events 21 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Diarrhea	55.1% 27/49 • Number of events 88 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Dyspepsia	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Lower gastrointestinal hemorrhage	6.1% 3/49 • Number of events 8 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Mucositis oral	65.3% 32/49 • Number of events 95 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Nausea	75.5% 37/49 • Number of events 169 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Oral pain	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Upper gastrointestinal hemorrhage	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Gastrointestinal disorders Vomiting	49.0% 24/49 • Number of events 61 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
General disorders Chest pain	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
General disorders Edema limbs	10.2% 5/49 • Number of events 9 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
General disorders Fatigue	98.0% 48/49 • Number of events 449 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
General disorders Fever	46.9% 23/49 • Number of events 41 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
General disorders Injection site reaction	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Hepatobiliary disorders Gallbladder obstruction	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Immune system disorders Hypersensitivity	8.2% 4/49 • Number of events 4 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Bladder infection	6.1% 3/49 • Number of events 5 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Catheter related infection	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Infection	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Pneumonia	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Sinusitis	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Skin infection	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Tooth infection	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Upper respiratory infection	6.1% 3/49 • Number of events 6 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Infections and infestations Urinary tract infection	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Injury, poisoning and procedural complications Wound dehiscence	4.1% 2/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Alanine aminotransferase increased	12.2% 6/49 • Number of events 9 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Alkaline phosphatase increased	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Aspartate aminotransferase increased	10.2% 5/49 • Number of events 6 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Bilirubin increased	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations CD4 lymphocytes decreased	2.0% 1/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Creatinine increased	8.2% 4/49 • Number of events 5 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Gamma-glutamyltransferase increased	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Leukocyte count decreased	24.5% 12/49 • Number of events 23 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Lymphocyte count decreased	4.1% 2/49 • Number of events 4 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Neutrophil count decreased	81.6% 40/49 • Number of events 153 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Platelet count decreased	65.3% 32/49 • Number of events 105 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Investigations Weight loss	4.1% 2/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Metabolism and nutrition disorders Anorexia	14.3% 7/49 • Number of events 11 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Metabolism and nutrition disorders Blood glucose increased	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Metabolism and nutrition disorders Dehydration	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Metabolism and nutrition disorders Serum calcium decreased	6.1% 3/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Metabolism and nutrition disorders Serum phosphate decreased	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Metabolism and nutrition disorders Serum potassium decreased	6.1% 3/49 • Number of events 4 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Metabolism and nutrition disorders Serum sodium decreased	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Musculoskeletal and connective tissue disorders Back pain	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Musculoskeletal and connective tissue disorders Bone pain	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Musculoskeletal and connective tissue disorders Joint pain	69.4% 34/49 • Number of events 190 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Musculoskeletal and connective tissue disorders Muscle weakness	2.0% 1/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	6.1% 3/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Musculoskeletal and connective tissue disorders Myalgia	73.5% 36/49 • Number of events 134 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Nervous system disorders Dizziness	2.0% 1/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Nervous system disorders Encephalopathy	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Nervous system disorders Headache	8.2% 4/49 • Number of events 4 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Nervous system disorders Peripheral motor neuropathy	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Nervous system disorders Peripheral sensory neuropathy	75.5% 37/49 • Number of events 345 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Nervous system disorders Syncope	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Nervous system disorders Taste alteration	4.1% 2/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Renal and urinary disorders Protein urine positive	40.8% 20/49 • Number of events 69 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Renal and urinary disorders Renal failure	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Reproductive system and breast disorders Vaginal dryness	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Dyspnea	57.1% 28/49 • Number of events 152 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Hemorrhage nasal	61.2% 30/49 • Number of events 169 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Hypoxia	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	18.4% 9/49 • Number of events 11 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Pneumothorax	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	4.1% 2/49 • Number of events 7 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Respiratory, thoracic and mediastinal disorders Respiratory tract hemorrhage	6.1% 3/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Alopecia	98.0% 48/49 • Number of events 454 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Dry skin	4.1% 2/49 • Number of events 4 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Hand-and-foot syndrome	24.5% 12/49 • Number of events 44 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Nail disorder	4.1% 2/49 • Number of events 5 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Pain of skin	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Pruritus	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Rash acneiform	2.0% 1/49 • Number of events 4 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Rash desquamating	6.1% 3/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Skin disorder	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	4.1% 2/49 • Number of events 3 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Skin and subcutaneous tissue disorders Skin ulceration	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Vascular disorders Hot flashes	4.1% 2/49 • Number of events 2 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Vascular disorders Hypertension	18.4% 9/49 • Number of events 11 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Vascular disorders Hypotension	2.0% 1/49 • Number of events 1 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).
Vascular disorders Thrombosis	12.2% 6/49 • Number of events 20 • Adverse events are assessed 15 days prior to registration, and during the Active Monitoring Phase at each evaluation 3 days prior to each cycle of treatment and at the end of treatment; up to 2 years. This study will utilize the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 for adverse event monitoring and reporting. All graded adverse events are reported. Any participant whose adverse event(s) were assessed during the time frame specified above were included in the Adverse Events data tables below (i.e. All study participants excluding those who cancelled prior to beginning treatment as specified in the Participant Flow section).

Additional Information

Donald W. Northfelt, MD, FACP

Mayo Clinic

Phone: 507/284-1159

Email: northfelt.donald@mayo.edu

Results disclosure agreements

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