Trial Outcomes & Findings for Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma (NCT NCT01646762)

Last Updated: 2017-10-16

Results Overview

A confirmed partial response or better will be considered synonymous with "success" and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + \<5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) noted as the objective status on two consecutive evaluations. The percentage of successes (confirmed PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. Confirmed PR or better will be evaluated using all cycles of treatment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

13 participants

Primary outcome timeframe

Up to 3 years

Results posted on

2017-10-16

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Chemotherapy) Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Chemotherapy) n=13 Participants Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Age, Continuous	70.0 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy) n=13 Participants Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Percentage of Patients Who Have a Confirmed Partial Response or Better	7.7 percentage of patients Interval 0.19 to 36.0

SECONDARY outcome

Timeframe: Time from registration to death due to any cause, assessed up to 3 years

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.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy) n=13 Participants Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Survival Time	3.7 months Interval 1.7 to The upper limit of the 95% confidence interval was not reached.

SECONDARY outcome

Timeframe: Time from registration to the earliest date of documentation of disease progression, assessed up to 3 years

The distribution of time to progression will be estimated using the method of Kaplan-Meier and the 3 month progression-free rate (percentage) will be provided. Progression is defined as: Any one or more of the following: Increase of 25% from lowest value in: * Serum M-component (absolute increase must be ≥ 0.5 g/dl * Serum M-component increase ≥ 1 g/dl, if lowest M component was ≥ 5 g/dl * Urine M-component (absolute increase must be ≥ 200 mg/24 h) * If at on study, the only measurable non-bone marrow parameter was free light chain (FLC), the difference between involved and uninvolved FLC levels (absolute increase must be \>10 mg/dl) * Bone marrow plasma cell percentage (absolute % must be ≥10%) Or any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder * Development of new soft tissue plasmacytomas or bone lesions * Hypercalcemia (≥11.5 mg/dl) * Decrease in hemoglobin of ≥2 g/dl * Serum creatinine level ≥2 mg/dl

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy) n=13 Participants Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Progression Free Survival at 3 Months	25.4 percentage of patients

SECONDARY outcome

Timeframe: Date at which the patient's earliest best objective status is first noted to be at least a partial response or better to the earliest date progression is documented, assessed up to 3 years

Population: All evaluable patients who have achieved a (unconfirmed or confirmed) partial response or better at the earliest best objective status are included in this analysis

Duration of response is defined for all evaluable patients who have achieved a partial response or better (stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + \<5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = partial response (PR) + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) ) as the date at which the patients earliest best objective status is first noted to be at least a partial response or better to the earliest date of progression is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy) n=2 Participants Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Duration of Response of All Evaluable Patients Who Have Achieved a Partial Response or Better	2.43 months The lower and upper limits of the full range are not reported to avoid identification of individuals.

SECONDARY outcome

Timeframe: Up to 3 years

Toxicity is defined as a grade 3 or higher adverse events that is classified as either possibly, probably, or definitely related to study treatment. The assignment of attribution to study treatment and grade (or degree of severity) of the adverse event are classified using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The percentage of patients with a maximum grade 3 or higher adverse event at least possibly related to the study treatment are reported below.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy) n=13 Participants Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 White blood cell decreased	30.8 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Neutrophil count decreased	38.5 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Platelet count decreased	38.5 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Fatigue	23.1 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Anemia	15.4 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Anorexia	7.7 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Edema limbs	7.7 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Hyponatremia	15.4 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Epistaxis	7.7 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Febrile neutropenia	7.7 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Infections and infestations	7.7 percentage of patients
Incidence of Toxicity as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 Lung infection	7.7 percentage of patients

SECONDARY outcome

Timeframe: Up to 3 years

Overall response rate (percentage) is defined as the percentage of patients with a partial response (PR) or better. A PR or better will be considered synonymous with "success" and is defined to be a stringent complete response (sCR = complete response (CR) + Normal serum FLC ratio + Absence of clonal cells in bone marrow), CR (= Negative immunofixation of the serum and urine + \<5%plasma cells in bone marrow + Disappearance of any soft tissue plasmacytomas + normalization of FLC ratio), very good partial response (VGPR = PR + Serum and urine M-component detectable by immunofixation but not on electrophoresis ), or PR (≥ 50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥ 90% or to \<200 mg per 24 h) noted as the objective status. The percentage of successes (PR or better) will be estimated by the number of successes divided by the total number of evaluable patients times 100. PR or better will be evaluated using all cycles of treatment.

Outcome measures

Outcome measures
Measure	Treatment (Chemotherapy) n=13 Participants Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Overall Response Rate	15 percentage of patients Interval 1.9 to 45.5

Adverse Events

Treatment (Chemotherapy)

Serious events: 11 serious events

Other events: 13 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Chemotherapy) n=13 participants at risk Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Blood and lymphatic system disorders Anemia	15.4% 2/13 • Number of events 3 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Blood and lymphatic system disorders Febrile neutropenia	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Cardiac disorders Atrial fibrillation	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Cardiac disorders Cardiac disorders - Other, specify	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Gastrointestinal disorders Diarrhea	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Gastrointestinal disorders Duodenal ulcer	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Gastrointestinal disorders Dysphagia	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Gastrointestinal disorders Esophageal necrosis	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Gastrointestinal disorders Gastric ulcer	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Gastrointestinal disorders Nausea	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Gastrointestinal disorders Vomiting	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
General disorders Edema limbs	7.7% 1/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Infections and infestations Enterocolitis infectious	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Infections and infestations Infections and infestations - Other, specify	15.4% 2/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Infections and infestations Lung infection	23.1% 3/13 • Number of events 3 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Infections and infestations Sepsis	7.7% 1/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations Lymphocyte count decreased	23.1% 3/13 • Number of events 6 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations Neutrophil count decreased	23.1% 3/13 • Number of events 3 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations Platelet count decreased	30.8% 4/13 • Number of events 5 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations White blood cell decreased	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Metabolism and nutrition disorders Hypercalcemia	23.1% 3/13 • Number of events 3 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Metabolism and nutrition disorders Hyperuricemia	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Metabolism and nutrition disorders Hypocalcemia	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Metabolism and nutrition disorders Hyponatremia	15.4% 2/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Metabolism and nutrition disorders Hypophosphatemia	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Musculoskeletal and connective tissue disorders Back pain	7.7% 1/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Nervous system disorders Encephalopathy	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Nervous system disorders Somnolence	7.7% 1/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Psychiatric disorders Confusion	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Renal and urinary disorders Chronic kidney disease	23.1% 3/13 • Number of events 3 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Respiratory, thoracic and mediastinal disorders Dyspnea	15.4% 2/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Respiratory, thoracic and mediastinal disorders Epistaxis	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Respiratory, thoracic and mediastinal disorders Respiratory failure	7.7% 1/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Skin and subcutaneous tissue disorders Skin ulceration	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Vascular disorders Hypotension	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Vascular disorders Thromboembolic event	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).

Other adverse events

Other adverse events
Measure	Treatment (Chemotherapy) n=13 participants at risk Patients receive 100 mg nab-paclitaxel IV over 30 minutes on days 1, 8, and 15 (with 1 week rest). Treatment repeats every 28 days for up to 12 courses/cycles in the absence of disease progression or unacceptable toxicity. After 12 cycles, continued treatment is at the discretion of the investigator until evidence of disease progression. Paclitaxel Albumin-Stabilized Nanoparticle Formulation: Given IV
Blood and lymphatic system disorders Anemia	53.8% 7/13 • Number of events 9 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Blood and lymphatic system disorders Febrile neutropenia	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Gastrointestinal disorders Diarrhea	61.5% 8/13 • Number of events 14 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Gastrointestinal disorders Nausea	53.8% 7/13 • Number of events 10 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
General disorders Edema limbs	7.7% 1/13 • Number of events 3 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
General disorders Fatigue	100.0% 13/13 • Number of events 28 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
General disorders Fever	38.5% 5/13 • Number of events 7 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
General disorders Malaise	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Infections and infestations Bronchial infection	7.7% 1/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Infections and infestations Sinusitis	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations Alanine aminotransferase increased	15.4% 2/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations Aspartate aminotransferase increased	23.1% 3/13 • Number of events 4 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations Blood bilirubin increased	15.4% 2/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations Creatinine increased	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations Lymphocyte count decreased	38.5% 5/13 • Number of events 6 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations Neutrophil count decreased	84.6% 11/13 • Number of events 18 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations Platelet count decreased	53.8% 7/13 • Number of events 11 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Investigations White blood cell decreased	100.0% 13/13 • Number of events 23 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Metabolism and nutrition disorders Anorexia	23.1% 3/13 • Number of events 6 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Metabolism and nutrition disorders Hyperglycemia	15.4% 2/13 • Number of events 3 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Metabolism and nutrition disorders Hyperuricemia	7.7% 1/13 • Number of events 1 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Nervous system disorders Peripheral motor neuropathy	7.7% 1/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Nervous system disorders Peripheral sensory neuropathy	92.3% 12/13 • Number of events 26 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Respiratory, thoracic and mediastinal disorders Dyspnea	61.5% 8/13 • Number of events 16 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Skin and subcutaneous tissue disorders Alopecia	7.7% 1/13 • Number of events 2 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Skin and subcutaneous tissue disorders Pruritus	15.4% 2/13 • Number of events 5 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Skin and subcutaneous tissue disorders Rash maculo-papular	38.5% 5/13 • Number of events 11 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).
Vascular disorders Hypotension	30.8% 4/13 • Number of events 4 • Adverse events were monitored within 14 days prior to registration, prior to subsequent treatment (visits at the end of each cycle), and at end of treatment, assessed up to 3 years. CTCAE term (AE description) and grade: The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for AE reporting. Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term (LLT).

Additional Information

Dr. Rafael Fonseca

Mayo Clinic

Phone: 480-301-4280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place