Trial Outcomes & Findings for Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer (NCT NCT00601900)

NCT ID: NCT00601900

Last Updated: 2025-05-23

Results Overview

The Primary Endpoint for this study was to compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. Progression-free survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions from baseline or the appearance of new lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 394 participants
• Primary outcome timeframe: From randomization until disease progression or death whichever occurs first, assessed up to 5 years
• Results posted on: 2025-05-23

Participant Flow

Participant milestones

Measure	Arm I (Endocrine Therapy With Monoclonal Antibody) Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (Endocrine Therapy) Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	195	199
Overall Study COMPLETED	195	196
Overall Study NOT COMPLETED	0	3

Reasons for withdrawal

Measure	Arm I (Endocrine Therapy With Monoclonal Antibody) Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (Endocrine Therapy) Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study Withdrawal by Subject	0	3

Baseline Characteristics

Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer

Baseline characteristics by cohort

Measure	Arm I (Endocrine Therapy With Monoclonal Antibody) n=195 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (Endocrine Therapy) n=196 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Total n=391 Participants Total of all reporting groups
Age, Continuous	55.5 years n=5 Participants	58.9 years n=7 Participants	57.7 years n=5 Participants
Sex: Female, Male Female	195 Participants n=5 Participants	196 Participants n=7 Participants	391 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	195 participants n=5 Participants	196 participants n=7 Participants	391 participants n=5 Participants
Endocrine Therapy Elected Letrozole	174 participants n=5 Participants	174 participants n=7 Participants	348 participants n=5 Participants
Endocrine Therapy Elected Tamoxifen	21 participants n=5 Participants	22 participants n=7 Participants	43 participants n=5 Participants

PRIMARY outcome

Timeframe: From randomization until disease progression or death whichever occurs first, assessed up to 5 years

Population: Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.

The Primary Endpoint for this study was to compare the progression-free survival of letrozole therapy alone with the combination of letrozole therapy plus bevacizumab as first-line treatment in women with estrogen- and/or progesterone-receptor-positive advanced breast cancer. Progression-free survival (PFS) was defined as the time from randomization until disease progression or death, whichever occurs first. The median PFS was estimated using the Kaplan-Meier method. Progression was assessed per RECIST criteria, and defined as at least a 20% increase in the sum of the longest diameters of target lesions from baseline or the appearance of new lesions.

Outcome measures

Measure	Arm I (Endocrine Therapy With Monoclonal Antibody) n=173 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (Endocrine Therapy) n=170 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival	20.2 months Interval 17.0 to 24.0	15.6 months Interval 12.9 to 19.7

SECONDARY outcome

Timeframe: At 12 months

Population: Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.

The 12 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 12 months after registration into the study.

Outcome measures

Measure	Arm I (Endocrine Therapy With Monoclonal Antibody) n=173 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (Endocrine Therapy) n=170 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
12 Month Progression Free Survival Rate	73 percentage of participants Interval 66.0 to 80.0	61 percentage of participants Interval 54.0 to 68.0

SECONDARY outcome

Timeframe: At 6 months

Population: Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.

The 6 month progression-free survival rate was defined as the proportion of patients who were alive progression-free 6 months after registration into the study.

Outcome measures

Measure	Arm I (Endocrine Therapy With Monoclonal Antibody) n=173 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (Endocrine Therapy) n=170 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
6 Month Progression-Free Survival Rate	87 percentage of participants Interval 82.0 to 93.0	77 percentage of participants Interval 71.0 to 83.0

SECONDARY outcome

Timeframe: Assessed up to 5 years

Population: Per protocol, the analysis of this endpoint was restricted to patients that elected letrozole as endocrine therapy and began treatment with measureable disease. A total of 213 patients (Arm A:106; Arm B:107) had measureable disease. Of the 213, 197 (Arm A:98, Arm B:99) patients were assessed for response during treatment.

Response was defined using RECIST criteria: Complete Response (CR): disappearance of all target lesions; Partial Response (PR) 30% decrease in sum of longest diameter of target lesions.

Outcome measures

Measure	Arm I (Endocrine Therapy With Monoclonal Antibody) n=98 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (Endocrine Therapy) n=99 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Objective Response Rate Complete Response (CR)	4 percentage of participants	7 percentage of participants
Objective Response Rate Partial Response (PR)	65 percentage of participants	42 percentage of participants
Objective Response Rate Stable Disease (SD)	22 percentage of participants	34 percentage of participants

SECONDARY outcome

Timeframe: Assessed up to 5 years

Population: Per protocol, the analysis of the primary endpoint was restricted to patients that elected letrozole as endocrine therapy. Of the 348 patients electing Letrozole, 5 did not receive treatment (1 on Arm I, and 4 on Arm II). This left 343 patients (173 on the Arm I and 170 on Arm II) evaluable for the primary endpoint.

OS is defined as the time from study entry to death from any cause. The median OS was estimated using the Kaplan-Meier method.

Outcome measures

Measure	Arm I (Endocrine Therapy With Monoclonal Antibody) n=173 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (Endocrine Therapy) n=170 Participants Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS)	47.2 months Interval 39.0 to 56.8	43.9 months Interval 37.6 to 49.6

SECONDARY outcome

Timeframe: From the time measurement criteria are met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 5 years

Defined by RECIST criteria.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 36 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

From randomization until first disease progression, early termination of protocol therapy due to toxicity or withdrawn consent, or going onto non-protocol therapy. Defined by RECIST criteria. The proportional hazards model will be used to compare the arms on time-to-treatment-failure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years

Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Tabulated by type, grade, and arm.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Endocrine Therapy With Monoclonal Antibody)

Serious events: 56 serious events

Other events: 174 other events

Deaths: 0 deaths

Arm II (Endocrine Therapy)

Serious events: 30 serious events

Other events: 145 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Endocrine Therapy With Monoclonal Antibody) n=195 participants at risk Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (Endocrine Therapy) n=196 participants at risk Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Hemoglobin decreased	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Cardiac disorders Cardiac valve disease	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Cardiac disorders Cardiopulmonary arrest	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Cardiac disorders Left ventricular failure	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Cardiac disorders Myocardial ischemia	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Cardiac disorders Pericardial effusion	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Abdominal distension	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Abdominal pain	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Colitis	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Constipation	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Diarrhea	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Enteritis	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Gastric hemorrhage	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Gastritis	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Ileus	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Nausea	4.1% 8/195 • Number of events 8 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Pancreatitis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Rectal hemorrhage	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Small intestinal obstruction	0.51% 1/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Vomiting	2.6% 5/195 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Chest pain	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Death NOS	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Disease progression	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.5% 3/196 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Edema limbs	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Fatigue	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Fever	3.1% 6/195 • Number of events 6 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Sudden death	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Hepatobiliary disorders Cholecystitis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Hepatobiliary disorders Hepatic pain	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Hepatobiliary disorders Hepatobiliary disease	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Appendicitis	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Appendicitis perforated	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Endocarditis infective	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Eye infection	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Infection	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Infection without neutropenia	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Pneumonia	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Sepsis	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Sinusitis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Skin infection	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Tooth infection	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Urinary tract infection	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Wound infection	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Injury, poisoning and procedural complications Fracture	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Injury, poisoning and procedural complications Intraoperative reproductive tract injury - Uterus	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Injury, poisoning and procedural complications Small intestinal anastomotic leak	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Injury, poisoning and procedural complications Wound dehiscence	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Alanine aminotransferase increased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Alkaline phosphatase increased	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Aspartate aminotransferase increased	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Blood bilirubin increased	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Cardiac troponin T increased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Creatinine increased	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations INR increased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Leukocyte count decreased	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Lymphocyte count decreased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Neutrophil count decreased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Platelet count decreased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Acidosis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Anorexia	2.1% 4/195 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Blood glucose increased	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Dehydration	2.1% 4/195 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum albumin decreased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum calcium decreased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum phosphate decreased	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum potassium decreased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum potassium increased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum sodium decreased	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Arthralgia	12.3% 24/195 • Number of events 31 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	6.1% 12/196 • Number of events 18 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Muscle weakness	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Osteonecrosis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Osteoporosis	0.51% 1/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Depressed level of consciousness	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Headache	6.7% 13/195 • Number of events 15 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	2.0% 4/196 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Intracranial hemorrhage	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Ischemia cerebrovascular	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Leukoencephalopathy	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Memory impairment	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Neuralgia	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Neurological disorder NOS	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Peripheral sensory neuropathy	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Seizure	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Speech disorder	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Syncope	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Psychiatric disorders Confusion	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Psychiatric disorders Depression	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Renal and urinary disorders Proteinuria	9.2% 18/195 • Number of events 21 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Renal and urinary disorders Renal failure	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Dyspnea	2.6% 5/195 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.0% 2/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Vascular disorders Hypertension	10.3% 20/195 • Number of events 23 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	3.1% 6/196 • Number of events 6 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Vascular disorders Hypotension	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Vascular disorders Thrombosis	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.5% 3/196 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.

Other adverse events

Measure	Arm I (Endocrine Therapy With Monoclonal Antibody) n=195 participants at risk Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.	Arm II (Endocrine Therapy) n=196 participants at risk Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
General disorders Flu-like symptoms	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Localized edema	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Pain	2.1% 4/195 • Number of events 15 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Hepatobiliary disorders Cholecystitis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Hepatobiliary disorders Hepatic pain	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Chest pain	1.0% 2/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Chills	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Edema limbs	1.5% 3/195 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Anal pain	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Colitis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Colonic hemorrhage	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Fatigue	9.7% 19/195 • Number of events 69 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	6.1% 12/196 • Number of events 21 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
General disorders Fever	12.3% 24/195 • Number of events 32 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	7.7% 15/196 • Number of events 18 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Constipation	1.0% 2/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Diarrhea	2.1% 4/195 • Number of events 29 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Dyspepsia	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Esophageal pain	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Esophagitis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Gastric ulcer	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Gastritis	0.51% 1/195 • Number of events 20 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Gastrointestinal disorder	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Hemorrhoids	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Mouth necrosis	0.51% 1/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Nausea	2.6% 5/195 • Number of events 19 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Oral hemorrhage	1.0% 2/195 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Rectal hemorrhage	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Toothache	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Vomiting	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Blood and lymphatic system disorders Blood disorder	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Blood and lymphatic system disorders Hemoglobin decreased	2.6% 5/195 • Number of events 12 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Blood and lymphatic system disorders Hemolysis	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Cardiac disorders Atrial fibrillation	0.51% 1/195 • Number of events 16 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Cardiac disorders Cardiac valve disease	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Cardiac disorders Left ventricular failure	2.1% 4/195 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Cardiac disorders Myocardial ischemia	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Cardiac disorders Palpitations	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Eye disorders Cataract	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Eye disorders Dry eye syndrome	0.51% 1/195 • Number of events 17 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Eye disorders Vision blurred	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Abdominal pain	1.5% 3/195 • Number of events 6 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Gastrointestinal disorders Anal hemorrhage	1.0% 2/195 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Immune system disorders Hypersensitivity	6.7% 13/195 • Number of events 27 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Appendicitis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Bladder infection	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Bronchitis	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Catheter related infection	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Conjunctivitis infective	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Endocarditis infective	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Eye infection	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Gingival infection	0.51% 1/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Infection	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Infectious colitis	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Lip infection	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Otitis externa	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Pharyngitis	0.51% 1/195 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Pneumonia	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.5% 3/196 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Sinusitis	3.6% 7/195 • Number of events 25 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.5% 3/196 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Skin infection	1.0% 2/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Tooth infection	2.1% 4/195 • Number of events 6 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Upper aerodigestive tract infection	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Upper respiratory infection	5.1% 10/195 • Number of events 14 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	2.6% 5/196 • Number of events 11 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Ureteritis	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Urinary tract infection	5.1% 10/195 • Number of events 16 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	2.0% 4/196 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Vaginal infection	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Vulvitis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Infections and infestations Wound infection	0.51% 1/195 • Number of events 6 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Injury, poisoning and procedural complications Fracture	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Injury, poisoning and procedural complications Wound dehiscence	3.1% 6/195 • Number of events 8 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Alanine aminotransferase increased	2.1% 4/195 • Number of events 8 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 6 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Alkaline phosphatase increased	2.1% 4/195 • Number of events 9 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Aspartate aminotransferase increased	3.6% 7/195 • Number of events 14 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.5% 3/196 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Blood bilirubin increased	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Creatinine increased	1.5% 3/195 • Number of events 7 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Gamma-glutamyltransferase increased	1.0% 2/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations INR increased	1.0% 2/195 • Number of events 10 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Leukocyte count decreased	0.51% 1/195 • Number of events 12 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Lymphocyte count decreased	1.0% 2/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Neutrophil count decreased	1.0% 2/195 • Number of events 14 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Platelet count decreased	1.5% 3/195 • Number of events 28 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Investigations Weight loss	2.6% 5/195 • Number of events 39 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Anorexia	1.0% 2/195 • Number of events 22 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Blood glucose increased	2.1% 4/195 • Number of events 26 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	2.0% 4/196 • Number of events 8 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Dehydration	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Glucose intolerance	0.51% 1/195 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Obesity	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum calcium decreased	2.1% 4/195 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum calcium increased	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum glucose decreased	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum magnesium decreased	0.51% 1/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum phosphate decreased	0.51% 1/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum potassium decreased	1.0% 2/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum potassium increased	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Metabolism and nutrition disorders Serum sodium decreased	2.1% 4/195 • Number of events 8 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Arthralgia	70.3% 137/195 • Number of events 1597 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	58.7% 115/196 • Number of events 1120 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Back pain	6.7% 13/195 • Number of events 37 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	3.6% 7/196 • Number of events 23 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Bone pain	5.1% 10/195 • Number of events 16 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Muscle weakness	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Myalgia	3.6% 7/195 • Number of events 14 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	3.1% 6/196 • Number of events 19 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Neck pain	0.51% 1/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.5% 3/196 • Number of events 6 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Osteonecrosis	1.0% 2/195 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Osteoporosis	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Musculoskeletal and connective tissue disorders Pain in extremity	3.1% 6/195 • Number of events 12 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 15 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Acoustic nerve disorder NOS	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Dizziness	2.1% 4/195 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Headache	43.6% 85/195 • Number of events 409 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	29.6% 58/196 • Number of events 245 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Ischemia cerebrovascular	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Memory impairment	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Neuralgia	1.5% 3/195 • Number of events 7 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Neurological disorder NOS	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Peripheral sensory neuropathy	2.1% 4/195 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Syncope	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Nervous system disorders Tremor	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Psychiatric disorders Anxiety	2.1% 4/195 • Number of events 6 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.5% 3/196 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Psychiatric disorders Confusion	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Psychiatric disorders Depression	2.6% 5/195 • Number of events 24 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Psychiatric disorders Insomnia	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.5% 3/196 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Psychiatric disorders Personality change	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Renal and urinary disorders Proteinuria	47.7% 93/195 • Number of events 818 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	6.6% 13/196 • Number of events 42 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Renal and urinary disorders Renal failure	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Renal and urinary disorders Urinary frequency	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Reproductive system and breast disorders Breast pain	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Reproductive system and breast disorders Irregular menstruation	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Reproductive system and breast disorders Pelvic pain	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Reproductive system and breast disorders Vaginal dryness	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 6 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	1.5% 3/195 • Number of events 16 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Cough	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.5% 3/195 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	2.6% 5/196 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.3% 24/195 • Number of events 160 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 5 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.51% 1/195 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Respiratory disorder	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Respiratory, thoracic and mediastinal disorders Voice alteration	1.0% 2/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Skin and subcutaneous tissue disorders Alopecia	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Skin and subcutaneous tissue disorders Rash desquamating	0.51% 1/195 • Number of events 2 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Skin and subcutaneous tissue disorders Skin disorder	0.51% 1/195 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Skin and subcutaneous tissue disorders Skin ulceration	0.51% 1/195 • Number of events 7 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Vascular disorders Hemorrhage	1.5% 3/195 • Number of events 4 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.00% 0/196 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Vascular disorders Hot flashes	6.2% 12/195 • Number of events 46 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	4.1% 8/196 • Number of events 34 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Vascular disorders Hypertension	59.0% 115/195 • Number of events 1029 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	31.1% 61/196 • Number of events 528 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Vascular disorders Hypotension	0.00% 0/195 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	0.51% 1/196 • Number of events 1 • All patients that received study treatment and were analyzed for adverse events are included in this summary.
Vascular disorders Thrombosis	3.1% 6/195 • Number of events 7 • All patients that received study treatment and were analyzed for adverse events are included in this summary.	1.0% 2/196 • Number of events 3 • All patients that received study treatment and were analyzed for adverse events are included in this summary.

Additional Information

Maura Dickler, M.D.

Memorial Sloan-Kettering Cancer Center

Email: dicklerm@mskcc.org

Results disclosure agreements

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

Restriction type: LTE60