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A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00320541
Recruitment Status : Completed
First Posted : May 3, 2006
Results First Posted : July 27, 2010
Last Update Posted : July 22, 2013
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: gemcitabine
Drug: paclitaxel
Drug: bevacizumab
Enrollment 187

Recruitment Details  
Pre-assignment Details 219 patients were screened; 28 patients were screen failures and were not assigned treatment.
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Period Title: Overall Study
Started 94 93
Completed 44 36
Not Completed 50 57
Reason Not Completed
Adverse Event             21             19
Protocol Violation             0             1
Withdrawal by Subject             12             16
Physician Decision             9             13
Other             3             4
Sponsor Decision             2             1
Death due to Study Disease             1             3
Death due to Adverse Event(s)             1             0
Protocol Entry Criterion Not Met             1             0
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G) Total
Hide Arm/Group Description paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days Total of all reporting groups
Overall Number of Baseline Participants 94 93 187
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 94 participants 93 participants 187 participants
57.5  (10.68) 56.8  (9.56) 57.2  (10.12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Female
94
 100.0%
93
 100.0%
187
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Caucasian 80 77 157
African 5 11 16
Hispanic 7 4 11
East Asian 2 1 3
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 94 participants 93 participants 187 participants
94 93 187
Basis for Pathological Diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Histopathological 84 84 168
Cytological 10 8 18
Missing 0 1 1
[1]
Measure Description: Methodology used for obtaining pathological diagnosis
Breakdown According to Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Fully Active- 0 57 60 117
Ambulatory, Restricted Strenuous Activity- 1 37 31 68
Missing 0 2 2
[1]
Measure Description: ECOG Performance Status classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death). In this study, ECOG performance status was assessed within 14 days of Visit 1. Patients were required to have a baseline ECOG Performance Status of 0 or 1 for study participation.
Breakdown by Estrogen Receptor (ER) Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Positive 60 67 127
Negative 33 25 58
Unknown 1 1 2
[1]
Measure Description: Breakdown of participants by ER status
Breakdown by Human Epidermal Growth Factor (HER-2 NEU) Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Not done 3 4 7
Positive 4 2 6
Negative 87 86 173
Missing 0 1 1
[1]
Measure Description: Breakdown of participants by HER-2 NEU status
Breakdown by Progesterone Receptor (PR) Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Not done 1 0 1
Positive 42 57 99
Negative 50 35 85
Unknown 1 1 2
[1]
Measure Description: Breakdown of participants by PR status
Breakdown of Disease-free Interval   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Less than or equal to 24 months 5 10 15
Greater than 24 months 6 2 8
Not applicable 83 81 164
[1]
Measure Description: Breakdown by treatment arm of disease-free interval which was defined as the duration between prior adjuvant chemotherapy stop date and disease recurrence date for applicable participants who received adjuvant chemotherapy.
Diagnosis by pathology   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Ductal breast carcinoma 76 79 155
Lobal breast carcinoma 9 6 15
Tubal breast carcinoma 0 0 0
Medullary breast carcinoma 0 0 0
Adenocystic breast carcinoma 0 0 0
Papillar breast carcinoma 0 0 0
Breast carcinoma 6 3 9
Other 3 5 8
[1]
Measure Description: Pathology of breast cancer diagnosis
Menopausal Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Not done 1 1 2
Pre-menopausal 18 18 36
Peri-menopausal 2 3 5
Post-menopausal 73 70 143
Unknown 0 1 1
[1]
Measure Description: Breakdown of menopausal status
Presence of Visceral Metastases   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Yes 68 66 134
No 25 24 49
Missing 1 3 4
[1]
Measure Description: Presence of visceral metastases at baseline visit
Prior Biological Treatment for This Cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
0 2 2
[1]
Measure Description: Number of participants, by treatment arm, who had received prior biological treatment for this cancer. NOTE: The total number of participants who received prior biological treatment does not equal the total number of participants in the trial because not all participants received prior biological treatment.
Prior Cancer Surgery   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
79 82 161
[1]
Measure Description: Number of participants, by treatment arm, who underwent prior surgery. NOTE: The total number of participants who underwent prior surgery does not equal the total number of participants in the trial because not all participants underwent prior surgery.
Prior Chemotherapy for This Cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
55 57 112
[1]
Measure Description: Number of participants, by treatment arm, who received prior chemotherapy for this cancer. NOTE: The total number of participants who received prior chemotherapy does not equal the total number of participants in the trial because not all participants received prior chemotherapy.
Prior Exposure to Taxanes   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
Yes 33 32 65
No 61 61 122
[1]
Measure Description: Number of participants previously treated with taxane chemotherapy including: Taxol (paclitaxel), Topotecan (docetaxel), or Abraxane (albumin-bound paclitaxel).
Prior Hormonal Treatment for This Cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
51 53 104
[1]
Measure Description: Number of participants, by treatment arm, who received prior hormonal treatment for this cancer. NOTE: The total number of participants who received prior hormonal treatment does not equal the total number of participants in the trial because not all participants received prior hormonal treatment.
Prior Immunological Treatment for This Cancer   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
2 0 2
[1]
Measure Description: Number of participants, by treatment arm, who received prior immunological treatment for this cancer. NOTE: The total number of participants who received prior immunnological treatment does not equal the total number of participants in the trial because not all participants received prior immunological treatment.
Prior Radiotherapy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 187 participants
50 55 105
[1]
Measure Description: Number of participants, by treatment arm, who received prior radiotherapy. NOTE: The total number of participants who received prior radiotherapy does not equal the total number of participants in the trial because not all participants received prior radiotherapy.
Body Surface Area (BSA) at Day 1 of Visit 1  
Mean (Standard Deviation)
Unit of measure:  Square meters (m2)
Number Analyzed 94 participants 93 participants 187 participants
1.8  (0.18) 1.8  (0.21) 1.8  (0.20)
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).
Time Frame baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Per-protocol population included intent-to-treat participants who met the following criteria: histological or cytological breast cancer diagnosis; baseline presence of measurable disease per RECIST; at least 1 dose of study drug; no current systemic anti-tumor therapy except protocol-specified therapy. One PB+G participant did not qualify.
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description:
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Number of Participants Analyzed 94 92
Mean (95% Confidence Interval)
Unit of Measure: proportion of responders
0.489
(0.385 to 0.595)
0.587
(0.479 to 0.689)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel Plus Bevacizumab (PB), Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Comments Assuming the response rate for the PB arm is 34% and the addition of gemcitabine will improve it to 54%, then a sample size of 170 evaluable participants (85 per arm) will give an 80% statistical power to detect the difference, using a 1-sided test at the significance level of 0.05. Confidence levels are exact binomial 95% Confidence Intervals.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments Statistical significance at 0.05 level was required.
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description PFS was measured from date of randomization to first date of disease progression or death from any cause. For participants not known to have died or had disease progression as of data-inclusion cut-off date, PFS duration was censored at date of last study visit prior to data-inclusion cut-off date.
Time Frame baseline to measured progressive disease or death up to 35 months (tumor assessments were performed every 2 cycles during study therapy; every 2 months during post-therapy until disease progression or new anticancer treatment initiated)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population=all randomized participants, eligible & ineligible. Participants with events: PB=74; PB+G=72. Censored participants: PB=20 PB+G=21.
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description:
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Number of Participants Analyzed 94 93
Median (Full Range)
Unit of Measure: months
8.8
(0.1 to 27.3)
11.3
(1.5 to 33.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel Plus Bevacizumab (PB), Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.247
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was measured from date of randomization to date of death from any cause. For participants not known to have died as of data-inclusion cut-off date, overall survival duration was censored at date of last study visit prior to the data cut-off date.
Time Frame baseline to death from any cause (up to 35 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat (ITT) population=all randomized participants, eligible & ineligible. Number of participants with events: PB=35; PB+G=34. Censored participants: PB=59;PB+G=59.
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description:
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Number of Participants Analyzed 94 93
Median (Full Range)
Unit of Measure: months
25.0
(0.1 to 34.6)
24.3
(1.5 to 33.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel Plus Bevacizumab (PB), Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy
Hide Description FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), & additional concerns of breast cancer (BCS). Total FACT-B scores range from 0-144, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for FACT-B is 7-8 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Time Frame Baseline through 30 days post therapy follow-up (up to 35 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description:
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Number of Participants Analyzed 60 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.0  (15.10) -10.8  (16.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel Plus Bevacizumab (PB), Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included treatment arm and baseline assessment.
5.Secondary Outcome
Title Physical Well Being (PWB) Subscale: Change From Baseline to End of Therapy
Hide Description The PWB subscale of FACT-B measures physical well-being. Total PWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Time Frame Baseline through 30 days post therapy follow-up (up to 35 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description:
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Number of Participants Analyzed 60 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.9  (5.90) -4.0  (6.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel Plus Bevacizumab (PB), Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.119
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included treatment arm and baseline assessment.
6.Secondary Outcome
Title Social/Family Well Being (SFWB) Subscale: Change From Baseline to End of Therapy
Hide Description The SFWB subscale of FACT-B measures social/family well-being. Total SFWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Time Frame Baseline through 30 days post therapy follow-up (up to 35 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description:
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Number of Participants Analyzed 61 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.0  (3.43) -1.9  (3.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel Plus Bevacizumab (PB), Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included treatment arm and baseline assessment.
7.Secondary Outcome
Title Emotional Well Being (EWB) Subscale: Change From Baseline to End of Therapy
Hide Description The EWB subscale of FACT-B measures emotional well-being. Total EWB scores range from 0 to 24, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Time Frame Baseline through 30 days post therapy follow-up (up to 35 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description:
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Number of Participants Analyzed 61 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.8  (3.17) -0.2  (3.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel Plus Bevacizumab (PB), Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included treatment arm and baseline assessment.
8.Secondary Outcome
Title Functional Well Being (FWB) Subscale: Change From Baseline to End of Therapy
Hide Description The FWB subscale of FACT-B measures functional well-being. Total FWB scores range from 0 to 28, with higher scores representing better HR-QOL. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Time Frame Baseline through 30 days post therapy follow-up (up to 35 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description:
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Number of Participants Analyzed 61 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (5.38) -3.8  (4.71)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel Plus Bevacizumab (PB), Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included treatment arm and baseline assessment.
9.Secondary Outcome
Title Breast Cancer Subscale (BCS): Change From Baseline to End of Therapy
Hide Description The BCS subscale of FACT-B measures additional concerns of breast cancer . Total BCS scores range from 0 to 36, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for BCS is 2-3 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Time Frame Baseline through 30 days post therapy follow-up (up to 35 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description:
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Number of Participants Analyzed 62 56
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.1  (5.02) -1.9  (4.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel Plus Bevacizumab (PB), Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included treatment arm and baseline assessment.
10.Secondary Outcome
Title Trial Outcome Index-Breast (TOI-B): Change From Baseline to End of Therapy
Hide Description The TOI-B represents the total of the subscales PWB,FWB, and BCS. Total TOI-B scores range from 0 to 92, with higher scores representing better HR-QOL. Minimally important differences estimates obtained for TOI is 5-6 points. FACT-B was assessed at baseline (prior to start of Cycle 1 [Day 1]), then prior to start of each subsequent cycle (approximately every 4 weeks) during therapy, through 30-day post therapy follow-up.
Time Frame Baseline through 30 days post therapy follow-up (up to 35 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Last Observation Carried Forward (LOCF) for all ITT patients with valid baseline and at least one valid post-baseline assessment
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description:
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
Overall Number of Participants Analyzed 60 55
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.5  (12.53) -9.1  (12.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Paclitaxel Plus Bevacizumab (PB), Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included treatment arm and baseline assessment.
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events (AEs) provided for all patients who received at least one dose of study drug. AEs are both study-drug related and non-study drug related. AEs represent all grades (1-5). Grade 1: mild adverse event (AE); Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening or disabling AE; Grade 5: death-related to AE.
 
Arm/Group Title Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Hide Arm/Group Description paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
All-Cause Mortality
Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   27/94 (28.72%)      36/93 (38.71%)    
Blood and lymphatic system disorders     
Anaemia  1  2/94 (2.13%)  2 2/93 (2.15%)  2
Febrile neutropenia  1  2/94 (2.13%)  3 9/93 (9.68%)  9
Leukopenia  1  1/94 (1.06%)  1 3/93 (3.23%)  3
Neutropenia  1  0/94 (0.00%)  0 4/93 (4.30%)  5
Thrombocytopenia  1  1/94 (1.06%)  1 1/93 (1.08%)  1
Cardiac disorders     
Arrhythmia  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Atrial fibrillation  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Cardiac failure congestive  1  0/94 (0.00%)  0 3/93 (3.23%)  3
Cardiomyopathy  1  0/94 (0.00%)  0 2/93 (2.15%)  2
Pericardial effusion  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Tachycardia  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Eye disorders     
Macular oedema  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Vision blurred  1  1/94 (1.06%)  1 1/93 (1.08%)  1
Gastrointestinal disorders     
Abdominal pain  1  3/94 (3.19%)  3 1/93 (1.08%)  1
Diarrhoea  1  1/94 (1.06%)  2 2/93 (2.15%)  2
Duodenal ulcer  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Duodenitis  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Dysphagia  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Ileus  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Nausea  1  2/94 (2.13%)  2 0/93 (0.00%)  0
Oesophagitis  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Pancreatitis  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Rectal haemorrhage  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Small intestinal obstruction  1  1/94 (1.06%)  2 0/93 (0.00%)  0
Vomiting  1  1/94 (1.06%)  1 0/93 (0.00%)  0
General disorders     
Asthenia  1  1/94 (1.06%)  1 1/93 (1.08%)  1
Fatigue  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Generalised oedema  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Oedema peripheral  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Pyrexia  1  2/94 (2.13%)  2 4/93 (4.30%)  4
Tenderness  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Visceral oedema  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Hepatobiliary disorders     
Hepatic failure  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Hyperbilirubinaemia  1  1/94 (1.06%)  1 1/93 (1.08%)  1
Infections and infestations     
Cellulitis  1  1/94 (1.06%)  1 5/93 (5.38%)  7
Clostridium difficile colitis  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Diverticulitis  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Gastroenteritis  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Infection  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Pneumonia  1  0/94 (0.00%)  0 2/93 (2.15%)  2
Sepsis  1  0/94 (0.00%)  0 1/93 (1.08%)  2
Sinusitis  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Staphylococcal infection  1  1/94 (1.06%)  1 1/93 (1.08%)  1
Upper respiratory tract infection  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Urinary tract infection  1  3/94 (3.19%)  4 1/93 (1.08%)  1
Vaginal infection  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Wound infection staphylococcal  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Injury, poisoning and procedural complications     
Compression fracture  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Investigations     
International normalised ratio  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Metabolism and nutrition disorders     
Anorexia  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Dehydration  1  4/94 (4.26%)  6 5/93 (5.38%)  5
Hypercalcaemia  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Musculoskeletal and connective tissue disorders     
Back pain  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Musculoskeletal chest pain  1  2/94 (2.13%)  2 1/93 (1.08%)  1
Myalgia  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Myopathy toxic  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Pain in extremity  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Hip fracture  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Nervous system disorders     
Aphasia  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Cerebrovascular disorder  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Headache  1  3/94 (3.19%)  3 1/93 (1.08%)  1
Lethargy  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Somnolence  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Syncope  1  2/94 (2.13%)  2 0/93 (0.00%)  0
Psychiatric disorders     
Confusional state  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Depression  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Mental status changes  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Renal and urinary disorders     
Haemorrhage urinary tract  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Nephrolithiasis  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Proteinuria  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Renal failure  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Renal failure acute  1  1/94 (1.06%)  1 1/93 (1.08%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Dyspnoea  1  2/94 (2.13%)  2 5/93 (5.38%)  5
Hypoxia  1  2/94 (2.13%)  2 2/93 (2.15%)  2
Lung infiltration  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Pleural effusion  1  1/94 (1.06%)  1 1/93 (1.08%)  1
Pulmonary embolism  1  2/94 (2.13%)  2 2/93 (2.15%)  2
Pulmonary hypertension  1  0/94 (0.00%)  0 2/93 (2.15%)  2
Pulmonary oedema  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Pulmonary thrombosis  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Skin and subcutaneous tissue disorders     
Erythema  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Skin ulcer  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Skin infection  1  1/94 (1.06%)  1 1/93 (1.08%)  1
Surgical and medical procedures     
Central venous catheter removal  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Vascular disorders     
Deep vein thrombosis  1  0/94 (0.00%)  0 1/93 (1.08%)  2
Haemorrhage  1  1/94 (1.06%)  1 0/93 (0.00%)  0
Hypertension  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Thrombosis  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Epistaxis  1  1/94 (1.06%)  1 1/93 (1.08%)  1
Pulmonary embolism  1  0/94 (0.00%)  0 1/93 (1.08%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Paclitaxel Plus Bevacizumab (PB) Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   93/94 (98.94%)      93/93 (100.00%)    
Blood and lymphatic system disorders     
Anaemia  1  18/94 (19.15%)  38 35/93 (37.63%)  76
Leukopenia  1  15/94 (15.96%)  43 23/93 (24.73%)  82
Neutropenia  1  39/94 (41.49%)  119 65/93 (69.89%)  169
Thrombocytopenia  1  7/94 (7.45%)  13 21/93 (22.58%)  43
Cardiac disorders     
Tachycardia  1  7/94 (7.45%)  8 6/93 (6.45%)  6
Eye disorders     
Lacrimation increased  1  6/94 (6.38%)  6 3/93 (3.23%)  3
Gastrointestinal disorders     
Abdominal pain  1  9/94 (9.57%)  11 9/93 (9.68%)  10
Constipation  1  29/94 (30.85%)  38 37/93 (39.78%)  54
Diarrhoea  1  36/94 (38.30%)  54 47/93 (50.54%)  58
Dyspepsia  1  9/94 (9.57%)  10 11/93 (11.83%)  12
Haemorrhoids  1  5/94 (5.32%)  6 6/93 (6.45%)  6
Nausea  1  40/94 (42.55%)  59 58/93 (62.37%)  85
Stomatitis  1  29/94 (30.85%)  36 33/93 (35.48%)  43
Vomiting  1  23/94 (24.47%)  30 30/93 (32.26%)  38
General disorders     
Asthenia  1  12/94 (12.77%)  13 5/93 (5.38%)  5
Chills  1  5/94 (5.32%)  5 10/93 (10.75%)  12
Fatigue  1  58/94 (61.70%)  104 74/93 (79.57%)  129
Influenza like illness  1  2/94 (2.13%)  2 5/93 (5.38%)  5
Oedema peripheral  1  19/94 (20.21%)  20 24/93 (25.81%)  32
Pain  1  8/94 (8.51%)  8 12/93 (12.90%)  13
Pyrexia  1  17/94 (18.09%)  21 25/93 (26.88%)  33
Infections and infestations     
Infection  1  1/94 (1.06%)  1 5/93 (5.38%)  6
Sinusitis  1  14/94 (14.89%)  21 13/93 (13.98%)  13
Upper respiratory tract infection  1  10/94 (10.64%)  14 13/93 (13.98%)  14
Urinary tract infection  1  18/94 (19.15%)  25 17/93 (18.28%)  22
Investigations     
Alanine aminotransferase increased  1  2/94 (2.13%)  2 12/93 (12.90%)  16
Aspartate aminotransferase increased  1  4/94 (4.26%)  4 13/93 (13.98%)  19
Blood alkaline phosphatase increased  1  1/94 (1.06%)  1 5/93 (5.38%)  7
Weight decreased  1  15/94 (15.96%)  15 16/93 (17.20%)  22
Metabolism and nutrition disorders     
Anorexia  1  19/94 (20.21%)  24 20/93 (21.51%)  28
Decreased appetite  1  5/94 (5.32%)  5 3/93 (3.23%)  3
Dehydration  1  8/94 (8.51%)  14 10/93 (10.75%)  14
Hyperglycaemia  1  4/94 (4.26%)  13 7/93 (7.53%)  12
Hypoalbuminaemia  1  0/94 (0.00%)  0 5/93 (5.38%)  6
Hypocalcaemia  1  1/94 (1.06%)  3 7/93 (7.53%)  9
Hypokalaemia  1  4/94 (4.26%)  5 6/93 (6.45%)  7
Hyponatraemia  1  3/94 (3.19%)  4 8/93 (8.60%)  10
Musculoskeletal and connective tissue disorders     
Arthralgia  1  23/94 (24.47%)  26 20/93 (21.51%)  23
Back pain  1  14/94 (14.89%)  15 18/93 (19.35%)  21
Bone pain  1  8/94 (8.51%)  9 14/93 (15.05%)  18
Musculoskeletal chest pain  1  6/94 (6.38%)  7 9/93 (9.68%)  11
Myalgia  1  20/94 (21.28%)  22 15/93 (16.13%)  15
Pain in extremity  1  11/94 (11.70%)  16 16/93 (17.20%)  19
Nervous system disorders     
Dizziness  1  14/94 (14.89%)  15 10/93 (10.75%)  10
Dysgeusia  1  9/94 (9.57%)  10 12/93 (12.90%)  13
Headache  1  23/94 (24.47%)  25 26/93 (27.96%)  30
Neuropathy  1  8/94 (8.51%)  9 10/93 (10.75%)  13
Neuropathy peripheral  1  14/94 (14.89%)  19 9/93 (9.68%)  10
Paraesthesia  1  5/94 (5.32%)  6 2/93 (2.15%)  2
Peripheral sensory neuropathy  1  49/94 (52.13%)  72 42/93 (45.16%)  53
Psychiatric disorders     
Anxiety  1  15/94 (15.96%)  17 9/93 (9.68%)  11
Confusional state  1  0/94 (0.00%)  0 5/93 (5.38%)  5
Depression  1  11/94 (11.70%)  11 8/93 (8.60%)  8
Insomnia  1  13/94 (13.83%)  16 18/93 (19.35%)  21
Renal and urinary disorders     
Dysuria  1  7/94 (7.45%)  7 5/93 (5.38%)  5
Pollakiuria  1  5/94 (5.32%)  5 3/93 (3.23%)  3
Proteinuria  1  3/94 (3.19%)  11 8/93 (8.60%)  11
Respiratory, thoracic and mediastinal disorders     
Cough  1  22/94 (23.40%)  30 25/93 (26.88%)  36
Dysphonia  1  1/94 (1.06%)  1 8/93 (8.60%)  9
Dyspnoea  1  22/94 (23.40%)  22 25/93 (26.88%)  29
Dyspnoea exertional  1  2/94 (2.13%)  3 6/93 (6.45%)  7
Nasal congestion  1  4/94 (4.26%)  4 7/93 (7.53%)  9
Pharyngolaryngeal pain  1  12/94 (12.77%)  14 10/93 (10.75%)  11
Rhinitis allergic  1  7/94 (7.45%)  8 8/93 (8.60%)  8
Rhinorrhoea  1  2/94 (2.13%)  2 7/93 (7.53%)  7
Skin and subcutaneous tissue disorders     
Alopecia  1  41/94 (43.62%)  42 44/93 (47.31%)  49
Dry skin  1  5/94 (5.32%)  5 10/93 (10.75%)  10
Erythema  1  7/94 (7.45%)  7 7/93 (7.53%)  10
Nail disorder  1  17/94 (18.09%)  25 21/93 (22.58%)  25
Pruritus  1  4/94 (4.26%)  4 5/93 (5.38%)  5
Rash  1  18/94 (19.15%)  23 28/93 (30.11%)  34
Vascular disorders     
Hot flush  1  6/94 (6.38%)  6 7/93 (7.53%)  9
Hypertension  1  22/94 (23.40%)  25 16/93 (17.20%)  23
Epistaxis  1  41/94 (43.62%)  51 40/93 (43.01%)  49
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Of 191 randomized patients, 4 patients were disqualified from inclusion in any efficacy or safety analyses due to significant Good Clinical Practice (GCP) violations; data is reported for the remaining 187 randomized patients.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00320541     History of Changes
Other Study ID Numbers: 10663
B9E-US-S377 ( Other Identifier: Eli Lilly and Company )
First Submitted: April 28, 2006
First Posted: May 3, 2006
Results First Submitted: April 26, 2010
Results First Posted: July 27, 2010
Last Update Posted: July 22, 2013