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Paclitaxel, Nab-paclitaxel, or Ixabepilone With or Without Bevacizumab in Treating Patients With Stage IIIC or Stage IV Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00785291
Recruitment Status : Active, not recruiting
First Posted : November 5, 2008
Results First Posted : July 2, 2015
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Estrogen Receptor Negative
Estrogen Receptor Positive
HER2/Neu Negative
HER2/Neu Positive
Progesterone Receptor Negative
Progesterone Receptor Positive
Recurrent Breast Carcinoma
Stage IIIC Breast Cancer AJCC v6
Stage IV Breast Cancer AJCC v6 and v7
Interventions Biological: Bevacizumab
Drug: Ixabepilone
Other: Laboratory Biomarker Analysis
Drug: Nab-paclitaxel
Drug: Paclitaxel
Other: Questionnaire Administration
Enrollment 799
Recruitment Details Between October 2008 - November 2011, a total of 799 participants were recruited.
Pre-assignment Details  
Arm/Group Title Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone)
Hide Arm/Group Description Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Period Title: Overall Study
Started 283 271 245
Completed 147 122 139
Not Completed 136 149 106
Reason Not Completed
Never began treatment             8             4             4
Adverse Event             39             70             56
Death             7             4             3
Withdrawal by Subject             35             36             17
Alternative Therapy             12             6             7
Complicating illness             6             4             4
Other Medical Reasons             29             25             15
Arm/Group Title Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone) Total
Hide Arm/Group Description Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11) Total of all reporting groups
Overall Number of Baseline Participants 283 271 245 799
Hide Baseline Analysis Population Description
All randomized participants are included in baseline characteristics.
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 283 participants 271 participants 245 participants 799 participants
20-29 2 2 1 5
30-39 15 18 17 50
40-49 52 56 55 163
50-59 109 89 86 284
60-69 74 74 68 216
70-79 24 28 15 67
80+ 7 4 3 14
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 271 participants 245 participants 799 participants
Female
277
  97.9%
268
  98.9%
243
  99.2%
788
  98.6%
Male
6
   2.1%
3
   1.1%
2
   0.8%
11
   1.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 271 participants 245 participants 799 participants
Hispanic or Latino
19
   6.7%
15
   5.5%
13
   5.3%
47
   5.9%
Not Hispanic or Latino
252
  89.0%
239
  88.2%
221
  90.2%
712
  89.1%
Unknown or Not Reported
12
   4.2%
17
   6.3%
11
   4.5%
40
   5.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 283 participants 271 participants 245 participants 799 participants
American Indian or Alaska Native
2
   0.7%
1
   0.4%
2
   0.8%
5
   0.6%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
3
   1.1%
0
   0.0%
1
   0.4%
4
   0.5%
Black or African American
42
  14.8%
45
  16.6%
26
  10.6%
113
  14.1%
White
220
  77.7%
214
  79.0%
206
  84.1%
640
  80.1%
More than one race
1
   0.4%
1
   0.4%
2
   0.8%
4
   0.5%
Unknown or Not Reported
15
   5.3%
10
   3.7%
8
   3.3%
33
   4.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 283 participants 271 participants 245 participants 799 participants
283 271 245 799
Prior Adjuvant Taxane  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 283 participants 271 participants 245 participants 799 participants
Yes 125 120 107 352
No 158 151 138 447
Hormone Receptor Status  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 283 participants 271 participants 245 participants 799 participants
ER/PgR Positive 201 195 178 574
ER/PgR Negative 82 76 67 225
Physician's Decision to use Bevacizumab  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 283 participants 271 participants 245 participants 799 participants
Bevacizumab planned 51 44 15 110
Bevacizumab not planned 8 4 8 20
Bevacizumab required 224 223 222 669
1.Primary Outcome
Title Progression Free Survival
Hide Description Progression-free survival (PFS) is defined as the interval from registration until first disease progression, regardless of site, or death resulting from any cause, which ever occurred first. Distribution was estimated using the Kaplan Meier product-limit method. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per Response Evaluation Criteria in Solid Tumors [RECIST] criteria).
Time Frame Time from randomization to progression or death due to any cause, whichever occurs first (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who never began protocol treatment were excluded.
Arm/Group Title Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone)
Hide Arm/Group Description:
Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Overall Number of Participants Analyzed 275 267 241
Median (95% Confidence Interval)
Unit of Measure: months
10.97
(9.79 to 12.42)
9.3
(8.15 to 10.45)
7.36
(6.21 to 8.18)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Paclitaxel), Arm B (Nab-paclitaxel)
Comments Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
1.00 to 1.45
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A (Paclitaxel), Arm C (Ixabepilone)
Comments Stratified log-rank tests are used for the two primary comparisons of PFS within an experimental arm relative to PFS within the control arm. The family-wise error rate will be controlled at a one-sided 0.025 level. This is achieved in a 3-arm trial with a common control group by conducting the marginal log-rank tests with a one-sided α = 0.0135. Sample size calculations are based on having high power to detect a hazard ratio of 1.36, in the control arm as compared to the experimental arms.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative). P-values are for a test of inferiority 2-sided and are unadjusted for multiple comparisons.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.55
Confidence Interval (2-Sided) 95%
1.28 to 1.87
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Objective Tumor Response Rate
Hide Description Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions).
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone)
Hide Arm/Group Description:
Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Overall Number of Participants Analyzed 275 267 241
Measure Type: Number
Unit of Measure: percentage of participants
38.2 34.1 25.6
3.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time from registration until treatment failure, defined as early termination of protocol therapy for any reason, first disease progression or death without progression. Surviving participants who were failure free were censored as date last known alive and failure free. Distribution was estimated using the Kaplan Meier product-limit method.
Time Frame Time from randomization until progression, death, or yearly termination of protocol therapy (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who never began protocol treatment were excluded.
Arm/Group Title Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone)
Hide Arm/Group Description:
Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Overall Number of Participants Analyzed 275 267 241
Median (95% Confidence Interval)
Unit of Measure: months
6.6
(5.62 to 7.2)
5.19
(4.83 to 5.55)
4.93
(4.21 to 5.29)
4.Secondary Outcome
Title 12 Month Progression Free Survival
Hide Description Percentage of participants who were alive and progression free at 12 months. The 12 month progression free survival, with 95% confidence interval, was estimated using the Kaplan Meier method.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who never began protocol treatment were excluded.
Arm/Group Title Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone)
Hide Arm/Group Description:
Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Overall Number of Participants Analyzed 275 267 241
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
45
(39 to 51)
36
(30 to 42)
28
(23 to 35)
5.Secondary Outcome
Title Overall Survival
Hide Description Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method.
Time Frame Time from randomization to death or last follow-up (up to 5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone)
Hide Arm/Group Description:
Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression.
Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
Overall Number of Participants Analyzed 275 267 241
Median (95% Confidence Interval)
Unit of Measure: months
26.55
(23.8 to 32.9)
23.52
(20.4 to 28.2)
23.53
(19.9 to 25.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Paclitaxel), Arm B (Nab-paclitaxel)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.92 to 1.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm A (Paclitaxel), Arm C (Ixabepilone)
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.038
Comments Tests were stratified by prior taxane therapy (yes/no) and hormone receptor status (positive/negative).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
1.01 to 1.61
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse event data was submitted on 774 participants (Arm A: 272, Arm B: 264, Arm C: 238)
 
Arm/Group Title Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone)
Hide Arm/Group Description Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment continues until progression. (closed to accrual as of 7/18/11)
All-Cause Mortality
Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/272 (23.90%)      80/264 (30.30%)      59/238 (24.79%)    
Blood and lymphatic system disorders       
Blood disorder † 1  0/272 (0.00%)  0 1/264 (0.38%)  2 0/238 (0.00%)  0
Bone marrow hypocellular † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Febrile neutropenia † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 1/238 (0.42%)  1
Hemoglobin decreased † 1  14/272 (5.15%)  17 18/264 (6.82%)  22 12/238 (5.04%)  14
Lymphatic disorder † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Cardiac disorders       
Atrial fibrillation † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 0/238 (0.00%)  0
Atrial tachycardia † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Left ventricular dysfunction † 1  0/272 (0.00%)  0 4/264 (1.52%)  4 0/238 (0.00%)  0
Left ventricular failure † 1  0/272 (0.00%)  0 3/264 (1.14%)  3 4/238 (1.68%)  5
Myocardial ischemia † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Palpitations † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Pericardial effusion † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Restrictive cardiomyopathy † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Sinus tachycardia † 1  2/272 (0.74%)  2 1/264 (0.38%)  1 1/238 (0.42%)  1
Stokes-Adams syndrome † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Supraventricular tachycardia † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Endocrine disorders       
Cushingoid † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Hypothyroidism † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Eye disorders       
Dry eye syndrome † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Eye pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Retinopathy † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Vision blurred † 1  2/272 (0.74%)  2 0/264 (0.00%)  0 2/238 (0.84%)  2
Watering eyes † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Gastrointestinal disorders       
Abdominal distension † 1  2/272 (0.74%)  2 1/264 (0.38%)  1 0/238 (0.00%)  0
Abdominal pain † 1  2/272 (0.74%)  2 2/264 (0.76%)  2 4/238 (1.68%)  4
Ascites † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 1/238 (0.42%)  1
Cecum perforation † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Colitis † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 2/238 (0.84%)  2
Colonic obstruction † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Colonic perforation † 1  1/272 (0.37%)  1 5/264 (1.89%)  5 0/238 (0.00%)  0
Constipation † 1  5/272 (1.84%)  5 6/264 (2.27%)  7 9/238 (3.78%)  10
Diarrhea † 1  7/272 (2.57%)  7 11/264 (4.17%)  12 11/238 (4.62%)  12
Dry mouth † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Duodenal hemorrhage † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Duodenal perforation † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Duodenal ulcer † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Dyspepsia † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 2/238 (0.84%)  2
Fecal incontinence † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Gastric hemorrhage † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Gastrointestinal disorder † 1  1/272 (0.37%)  1 2/264 (0.76%)  4 0/238 (0.00%)  0
Gastrointestinal pain † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Gingival pain † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Hemorrhoidal hemorrhage † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Hemorrhoids † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Ileus † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Intra-abdominal hemorrhage † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 1/238 (0.42%)  1
Lower gastrointestinal hemorrhage † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Mucositis oral † 1  2/272 (0.74%)  2 6/264 (2.27%)  6 1/238 (0.42%)  1
Nausea † 1  6/272 (2.21%)  6 19/264 (7.20%)  21 21/238 (8.82%)  24
Oral hemorrhage † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Oral pain † 1  2/272 (0.74%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Rectal hemorrhage † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 2/238 (0.84%)  2
Small intestinal obstruction † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Small intestinal perforation † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Stomach pain † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Toothache † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Upper gastrointestinal hemorrhage † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Vomiting † 1  6/272 (2.21%)  6 12/264 (4.55%)  14 15/238 (6.30%)  16
General disorders       
Chest pain † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 3/238 (1.26%)  3
Chills † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 0/238 (0.00%)  0
Death NOS † 1  2/272 (0.74%)  2 2/264 (0.76%)  2 0/238 (0.00%)  0
Disease progression † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 2/238 (0.84%)  2
Edema limbs † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 3/238 (1.26%)  4
Fatigue † 1  43/272 (15.81%)  56 56/264 (21.21%)  64 40/238 (16.81%)  44
Fever † 1  2/272 (0.74%)  2 7/264 (2.65%)  7 2/238 (0.84%)  3
General symptom † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 0/238 (0.00%)  0
Localized edema † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Multi-organ failure † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Pain † 1  2/272 (0.74%)  2 1/264 (0.38%)  1 2/238 (0.84%)  2
Hepatobiliary disorders       
Cholecystitis † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Hepatic failure † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 2/238 (0.84%)  2
Hepatobiliary disease † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Immune system disorders       
Cytokine release syndrome † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Hypersensitivity † 1  3/272 (1.10%)  3 2/264 (0.76%)  2 2/238 (0.84%)  2
Infections and infestations       
Abdominal infection † 1  0/272 (0.00%)  0 2/264 (0.76%)  3 0/238 (0.00%)  0
Anorectal infection † 1  2/272 (0.74%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Biliary tract infection † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Bladder infection † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Catheter related infection † 1  5/272 (1.84%)  5 4/264 (1.52%)  4 3/238 (1.26%)  3
Colitis, infectious (e.g., Clostridium difficile) † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Device related infection † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Encephalitis infection † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Eye infection † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Gallbladder infection † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Infection † 1  0/272 (0.00%)  0 3/264 (1.14%)  3 4/238 (1.68%)  5
Infection without neutropenia † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Infectious colitis † 1  2/272 (0.74%)  2 0/264 (0.00%)  0 2/238 (0.84%)  2
Kidney infection † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Mucosal infection † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Opportunistic infection † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 1/238 (0.42%)  1
Peritoneal infection † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Pneumonia † 1  4/272 (1.47%)  4 5/264 (1.89%)  6 7/238 (2.94%)  7
Salivary gland infection † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 2/238 (0.84%)  2
Sepsis † 1  3/272 (1.10%)  3 4/264 (1.52%)  4 1/238 (0.42%)  1
Sinusitis † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 0/238 (0.00%)  0
Skin infection † 1  5/272 (1.84%)  5 4/264 (1.52%)  4 0/238 (0.00%)  0
Soft tissue infection † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Tooth infection † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Upper respiratory infection † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 2/238 (0.84%)  2
Urinary tract infection † 1  2/272 (0.74%)  2 6/264 (2.27%)  6 5/238 (2.10%)  5
Uterine infection † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Vulvitis † 1  1/272 (0.37%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Wound infection † 1  1/272 (0.37%)  1 3/264 (1.14%)  4 0/238 (0.00%)  0
Injury, poisoning and procedural complications       
Fracture † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 3/238 (1.26%)  3
Injury to carotid artery † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Intraoperative gastrointestinal injury - Teeth † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Vascular access complication † 1  0/272 (0.00%)  0 1/264 (0.38%)  3 1/238 (0.42%)  1
Wound dehiscence † 1  2/272 (0.74%)  3 2/264 (0.76%)  2 0/238 (0.00%)  0
Investigations       
ADH abnormal † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Activated partial thromboplastin time prolonged † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Alanine aminotransferase increased † 1  1/272 (0.37%)  1 3/264 (1.14%)  3 1/238 (0.42%)  1
Alkaline phosphatase increased † 1  1/272 (0.37%)  1 3/264 (1.14%)  4 3/238 (1.26%)  3
Aspartate aminotransferase increased † 1  1/272 (0.37%)  1 4/264 (1.52%)  4 6/238 (2.52%)  7
Blood bilirubin increased † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 1/238 (0.42%)  1
Creatinine increased † 1  2/272 (0.74%)  2 2/264 (0.76%)  3 3/238 (1.26%)  3
INR increased † 1  0/272 (0.00%)  0 2/264 (0.76%)  3 2/238 (0.84%)  2
Laboratory test abnormal † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Leukocyte count decreased † 1  7/272 (2.57%)  8 17/264 (6.44%)  19 7/238 (2.94%)  9
Lymphocyte count decreased † 1  3/272 (1.10%)  3 2/264 (0.76%)  2 6/238 (2.52%)  6
Neutrophil count decreased † 1  16/272 (5.88%)  19 36/264 (13.64%)  39 14/238 (5.88%)  16
Platelet count decreased † 1  3/272 (1.10%)  3 13/264 (4.92%)  13 10/238 (4.20%)  10
Weight gain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Weight loss † 1  0/272 (0.00%)  0 5/264 (1.89%)  7 4/238 (1.68%)  6
Metabolism and nutrition disorders       
Anorexia † 1  6/272 (2.21%)  7 10/264 (3.79%)  12 7/238 (2.94%)  7
Blood bicarbonate decreased † 1  0/272 (0.00%)  0 3/264 (1.14%)  3 0/238 (0.00%)  0
Blood glucose increased † 1  6/272 (2.21%)  7 8/264 (3.03%)  9 8/238 (3.36%)  10
Blood uric acid increased † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Dehydration † 1  3/272 (1.10%)  3 9/264 (3.41%)  10 11/238 (4.62%)  12
Serum albumin decreased † 1  1/272 (0.37%)  1 9/264 (3.41%)  10 6/238 (2.52%)  7
Serum calcium decreased † 1  4/272 (1.47%)  6 8/264 (3.03%)  9 4/238 (1.68%)  4
Serum magnesium decreased † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Serum phosphate decreased † 1  2/272 (0.74%)  2 3/264 (1.14%)  3 1/238 (0.42%)  1
Serum potassium decreased † 1  5/272 (1.84%)  5 5/264 (1.89%)  6 9/238 (3.78%)  9
Serum potassium increased † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Serum sodium decreased † 1  3/272 (1.10%)  3 8/264 (3.03%)  9 7/238 (2.94%)  7
Serum sodium increased † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  1/272 (0.37%)  1 5/264 (1.89%)  5 5/238 (2.10%)  6
Back pain † 1  4/272 (1.47%)  5 8/264 (3.03%)  10 5/238 (2.10%)  6
Bone pain † 1  1/272 (0.37%)  1 3/264 (1.14%)  3 5/238 (2.10%)  5
Chest wall pain † 1  4/272 (1.47%)  5 1/264 (0.38%)  1 1/238 (0.42%)  1
Joint disorder † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Muscle weakness † 1  1/272 (0.37%)  1 4/264 (1.52%)  4 4/238 (1.68%)  5
Muscle weakness lower limb † 1  1/272 (0.37%)  2 0/264 (0.00%)  0 1/238 (0.42%)  1
Musculoskeletal disorder † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Myalgia † 1  8/272 (2.94%)  10 12/264 (4.55%)  13 10/238 (4.20%)  10
Osteonecrosis † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Pain in extremity † 1  3/272 (1.10%)  5 0/264 (0.00%)  0 2/238 (0.84%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor pain † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Nervous system disorders       
Ataxia † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 0/238 (0.00%)  0
Cognitive disturbance † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Depressed level of consciousness † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Dizziness † 1  2/272 (0.74%)  2 3/264 (1.14%)  3 3/238 (1.26%)  4
Dysgeusia † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 2/238 (0.84%)  2
Headache † 1  4/272 (1.47%)  6 5/264 (1.89%)  6 5/238 (2.10%)  5
Intracranial hemorrhage † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Ischemia cerebrovascular † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Leukoencephalopathy † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Mini mental status examination abnormal † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Neuralgia † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 2/238 (0.84%)  2
Neurological disorder NOS † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Peripheral motor neuropathy † 1  5/272 (1.84%)  5 10/264 (3.79%)  11 8/238 (3.36%)  8
Peripheral sensory neuropathy † 1  35/272 (12.87%)  45 43/264 (16.29%)  50 32/238 (13.45%)  38
Seizure † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 2/238 (0.84%)  2
Speech disorder † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Syncope † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 0/238 (0.00%)  0
Psychiatric disorders       
Anxiety † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 0/238 (0.00%)  0
Confusion † 1  1/272 (0.37%)  1 4/264 (1.52%)  4 3/238 (1.26%)  3
Depression † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 2/238 (0.84%)  2
Insomnia † 1  1/272 (0.37%)  1 3/264 (1.14%)  3 2/238 (0.84%)  2
Renal and urinary disorders       
Glomerular filtration rate decreased † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Hemoglobin urine positive † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Hemorrhage urinary tract † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 0/238 (0.00%)  0
Proteinuria † 1  8/272 (2.94%)  9 10/264 (3.79%)  10 7/238 (2.94%)  7
Renal failure † 1  3/272 (1.10%)  3 1/264 (0.38%)  1 1/238 (0.42%)  1
Ureteric fistula † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Ureteric obstruction † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Urinary incontinence † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Urogenital disorder † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Reproductive system and breast disorders       
Pelvic pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Perineal pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Adult respiratory distress syndrome † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 0/238 (0.00%)  0
Allergic rhinitis † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Cough † 1  6/272 (2.21%)  6 4/264 (1.52%)  6 3/238 (1.26%)  3
Dyspnea † 1  12/272 (4.41%)  12 13/264 (4.92%)  15 15/238 (6.30%)  17
Epistaxis † 1  2/272 (0.74%)  2 3/264 (1.14%)  4 9/238 (3.78%)  9
Hypoxia † 1  2/272 (0.74%)  2 4/264 (1.52%)  4 3/238 (1.26%)  3
Laryngoscopy abnormal † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 2/238 (0.84%)  2
Nasal congestion † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 1/238 (0.42%)  1
Pleural effusion † 1  1/272 (0.37%)  1 4/264 (1.52%)  4 2/238 (0.84%)  2
Pleuritic pain † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 0/238 (0.00%)  0
Pneumonitis † 1  1/272 (0.37%)  1 4/264 (1.52%)  4 3/238 (1.26%)  3
Pneumothorax † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Pulmonary hypertension † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Respiratory disorder † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Voice alteration † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  2
Skin and subcutaneous tissue disorders       
Alopecia † 1  4/272 (1.47%)  5 7/264 (2.65%)  9 6/238 (2.52%)  7
Decubitus ulcer † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Hand-and-foot syndrome † 1  0/272 (0.00%)  0 3/264 (1.14%)  3 0/238 (0.00%)  0
Nail disorder † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 1/238 (0.42%)  1
Pain of skin † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 0/238 (0.00%)  0
Petechiae † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Pruritus † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 1/238 (0.42%)  1
Rash acneiform † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 2/238 (0.84%)  3
Rash desquamating † 1  2/272 (0.74%)  2 3/264 (1.14%)  3 2/238 (0.84%)  2
Skin disorder † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Skin ulceration † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Sweating † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 0/238 (0.00%)  0
Urticaria † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Vascular disorders       
Hemorrhage † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Hypertension † 1  15/272 (5.51%)  17 17/264 (6.44%)  17 17/238 (7.14%)  17
Hypotension † 1  0/272 (0.00%)  0 4/264 (1.52%)  4 4/238 (1.68%)  4
Lymphedema † 1  2/272 (0.74%)  3 0/264 (0.00%)  0 0/238 (0.00%)  0
Phlebitis † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Thrombosis † 1  7/272 (2.57%)  9 7/264 (2.65%)  7 4/238 (1.68%)  4
Vascular disorder † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 1/238 (0.42%)  1
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A (Paclitaxel) Arm B (Nab-paclitaxel) Arm C (Ixabepilone)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   263/272 (96.69%)      248/264 (93.94%)      230/238 (96.64%)    
Blood and lymphatic system disorders       
Anemia † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Blood disorder † 1  1/272 (0.37%)  4 2/264 (0.76%)  5 2/238 (0.84%)  4
Bone marrow hypocellular † 1  3/272 (1.10%)  6 1/264 (0.38%)  2 2/238 (0.84%)  2
Febrile neutropenia † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 1/238 (0.42%)  1
Hemoglobin decreased † 1  49/272 (18.01%)  202 49/264 (18.56%)  165 40/238 (16.81%)  128
Lymph node pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Lymphatic disorder † 1  1/272 (0.37%)  4 0/264 (0.00%)  0 1/238 (0.42%)  1
Cardiac disorders       
Atrial fibrillation † 1  1/272 (0.37%)  3 0/264 (0.00%)  0 1/238 (0.42%)  1
Atrial tachycardia † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Cardiac disorder † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Cardiac pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Edema † 1  3/272 (1.10%)  5 0/264 (0.00%)  0 0/238 (0.00%)  0
Left ventricular dysfunction † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Left ventricular failure † 1  0/272 (0.00%)  0 2/264 (0.76%)  4 0/238 (0.00%)  0
Myocardial ischemia † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Palpitations † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Pericardial effusion † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Sinus bradycardia † 1  1/272 (0.37%)  1 1/264 (0.38%)  2 0/238 (0.00%)  0
Sinus tachycardia † 1  3/272 (1.10%)  20 3/264 (1.14%)  7 3/238 (1.26%)  3
Supraventricular tachycardia † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Ear and labyrinth disorders       
Ear disorder † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Ear pain † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 1/238 (0.42%)  1
Hearing impaired † 1  1/272 (0.37%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Tinnitus † 1  1/272 (0.37%)  1 1/264 (0.38%)  2 3/238 (1.26%)  5
Endocrine disorders       
Cushingoid † 1  1/272 (0.37%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Eye disorders       
Cataract † 1  2/272 (0.74%)  28 2/264 (0.76%)  3 0/238 (0.00%)  0
Diplopia † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Dry eye syndrome † 1  1/272 (0.37%)  1 2/264 (0.76%)  4 3/238 (1.26%)  3
Eye disorder † 1  2/272 (0.74%)  2 4/264 (1.52%)  5 0/238 (0.00%)  0
Flashing vision † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 1/238 (0.42%)  1
Optic nerve disorder † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Photophobia † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Vision blurred † 1  4/272 (1.47%)  12 13/264 (4.92%)  31 2/238 (0.84%)  3
Vitreous hemorrhage † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Watering eyes † 1  2/272 (0.74%)  2 9/264 (3.41%)  19 0/238 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension † 1  2/272 (0.74%)  4 2/264 (0.76%)  2 0/238 (0.00%)  0
Abdominal pain † 1  9/272 (3.31%)  13 7/264 (2.65%)  10 10/238 (4.20%)  12
Anal fistula † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Anal hemorrhage † 1  2/272 (0.74%)  2 1/264 (0.38%)  1 1/238 (0.42%)  2
Anal pain † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Ascites † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Cheilitis † 1  1/272 (0.37%)  4 0/264 (0.00%)  0 1/238 (0.42%)  1
Colitis † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Colonic hemorrhage † 1  1/272 (0.37%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Constipation † 1  35/272 (12.87%)  84 36/264 (13.64%)  95 45/238 (18.91%)  87
Diarrhea † 1  35/272 (12.87%)  74 36/264 (13.64%)  67 45/238 (18.91%)  85
Dry mouth † 1  3/272 (1.10%)  6 3/264 (1.14%)  4 4/238 (1.68%)  6
Dyspepsia † 1  11/272 (4.04%)  20 13/264 (4.92%)  19 20/238 (8.40%)  34
Dysphagia † 1  4/272 (1.47%)  5 3/264 (1.14%)  4 1/238 (0.42%)  1
Ear, nose and throat examination abnormal † 1  3/272 (1.10%)  3 5/264 (1.89%)  6 5/238 (2.10%)  6
Esophagitis † 1  2/272 (0.74%)  2 1/264 (0.38%)  1 0/238 (0.00%)  0
Flatulence † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Gastric ulcer † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Gastritis † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 2/238 (0.84%)  2
Gastrointestinal disorder † 1  5/272 (1.84%)  11 1/264 (0.38%)  1 3/238 (1.26%)  5
Gastroscopy abnormal † 1  0/272 (0.00%)  0 1/264 (0.38%)  2 0/238 (0.00%)  0
Gingival pain † 1  2/272 (0.74%)  5 1/264 (0.38%)  1 2/238 (0.84%)  2
Hemorrhoidal hemorrhage † 1  3/272 (1.10%)  5 1/264 (0.38%)  1 0/238 (0.00%)  0
Hemorrhoids † 1  3/272 (1.10%)  3 2/264 (0.76%)  6 8/238 (3.36%)  15
Lower gastrointestinal hemorrhage † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Mucositis oral † 1  21/272 (7.72%)  35 22/264 (8.33%)  40 16/238 (6.72%)  32
Nausea † 1  48/272 (17.65%)  92 52/264 (19.70%)  123 75/238 (31.51%)  160
Oral hemorrhage † 1  1/272 (0.37%)  1 4/264 (1.52%)  4 5/238 (2.10%)  9
Oral pain † 1  2/272 (0.74%)  2 4/264 (1.52%)  10 1/238 (0.42%)  1
Pancreatitis † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Periodontal disease † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 2/238 (0.84%)  11
Peritoneal pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Proctitis † 1  1/272 (0.37%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Rectal bleeding/hematochezia † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Rectal hemorrhage † 1  9/272 (3.31%)  24 8/264 (3.03%)  11 5/238 (2.10%)  8
Rectal pain † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Stomach pain † 1  1/272 (0.37%)  1 1/264 (0.38%)  2 1/238 (0.42%)  1
Tooth development disorder † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Tooth disorder † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Toothache † 1  1/272 (0.37%)  1 1/264 (0.38%)  2 1/238 (0.42%)  1
Upper gastrointestinal hemorrhage † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 2/238 (0.84%)  2
Vomiting † 1  18/272 (6.62%)  24 27/264 (10.23%)  45 29/238 (12.18%)  48
General disorders       
Chest pain † 1  6/272 (2.21%)  11 2/264 (0.76%)  2 3/238 (1.26%)  3
Chills † 1  2/272 (0.74%)  2 4/264 (1.52%)  7 4/238 (1.68%)  5
Edema limbs † 1  11/272 (4.04%)  37 13/264 (4.92%)  37 11/238 (4.62%)  46
Facial pain † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Fatigue † 1  208/272 (76.47%)  1397 213/264 (80.68%)  1186 205/238 (86.13%)  1036
Fever † 1  4/272 (1.47%)  5 5/264 (1.89%)  6 7/238 (2.94%)  14
Flu-like symptoms † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 1/238 (0.42%)  1
Gait abnormal † 1  0/272 (0.00%)  0 1/264 (0.38%)  2 0/238 (0.00%)  0
General symptom † 1  1/272 (0.37%)  4 2/264 (0.76%)  4 2/238 (0.84%)  3
Ill-defined disorder † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Injection site reaction † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 3/238 (1.26%)  5
Localized edema † 1  4/272 (1.47%)  13 1/264 (0.38%)  2 2/238 (0.84%)  2
Pain † 1  21/272 (7.72%)  34 13/264 (4.92%)  16 12/238 (5.04%)  24
Hepatobiliary disorders       
Gallbladder obstruction † 1  1/272 (0.37%)  5 0/264 (0.00%)  0 0/238 (0.00%)  0
Hepatic failure † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Hepatic pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Immune system disorders       
Hypersensitivity † 1  23/272 (8.46%)  32 28/264 (10.61%)  48 17/238 (7.14%)  19
Immune system disorder † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Infections and infestations       
Bladder infection † 1  3/272 (1.10%)  7 3/264 (1.14%)  5 2/238 (0.84%)  2
Bronchitis † 1  3/272 (1.10%)  4 1/264 (0.38%)  1 2/238 (0.84%)  2
Catheter related infection † 1  4/272 (1.47%)  4 1/264 (0.38%)  1 0/238 (0.00%)  0
Colitis, infectious (e.g., Clostridium difficile) † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Conjunctivitis infective † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Device related infection † 1  2/272 (0.74%)  7 0/264 (0.00%)  0 2/238 (0.84%)  3
Esophageal infection † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Eye infection † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Gingival infection † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Infection † 1  8/272 (2.94%)  9 6/264 (2.27%)  7 1/238 (0.42%)  1
Infection with grade 3 or 4 neutropenia † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Infection without neutropenia † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 1/238 (0.42%)  1
Infectious colitis † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Kidney infection † 1  2/272 (0.74%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Laryngitis † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Mucosal infection † 1  0/272 (0.00%)  0 2/264 (0.76%)  4 0/238 (0.00%)  0
Nail infection † 1  2/272 (0.74%)  2 3/264 (1.14%)  5 2/238 (0.84%)  2
Otitis media † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Paranasal sinus infection † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Peripheral nerve infection † 1  1/272 (0.37%)  1 1/264 (0.38%)  2 0/238 (0.00%)  0
Pneumonia † 1  4/272 (1.47%)  4 0/264 (0.00%)  0 1/238 (0.42%)  1
Rhinitis infective † 1  2/272 (0.74%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Salivary gland infection † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Sepsis † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Sinusitis † 1  6/272 (2.21%)  7 6/264 (2.27%)  7 3/238 (1.26%)  6
Skin infection † 1  4/272 (1.47%)  4 2/264 (0.76%)  2 1/238 (0.42%)  1
Small intestine infection † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Soft tissue infection † 1  1/272 (0.37%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Tooth infection † 1  2/272 (0.74%)  2 3/264 (1.14%)  3 2/238 (0.84%)  2
Upper aerodigestive tract infection † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Upper respiratory infection † 1  5/272 (1.84%)  5 4/264 (1.52%)  5 6/238 (2.52%)  6
Ureteritis † 1  1/272 (0.37%)  2 1/264 (0.38%)  1 0/238 (0.00%)  0
Urinary tract infection † 1  9/272 (3.31%)  12 6/264 (2.27%)  6 9/238 (3.78%)  14
Vaginal infection † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Vulvitis † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Wound infection † 1  0/272 (0.00%)  0 2/264 (0.76%)  2 2/238 (0.84%)  2
Injury, poisoning and procedural complications       
Bruising † 1  0/272 (0.00%)  0 4/264 (1.52%)  5 1/238 (0.42%)  1
Dermatitis radiation † 1  0/272 (0.00%)  0 1/264 (0.38%)  2 0/238 (0.00%)  0
Fracture † 1  3/272 (1.10%)  3 1/264 (0.38%)  1 0/238 (0.00%)  0
Intraoperative breast injury † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Seroma † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Vascular access complication † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 1/238 (0.42%)  1
Wound dehiscence † 1  10/272 (3.68%)  28 10/264 (3.79%)  32 9/238 (3.78%)  15
Investigations       
Alanine aminotransferase increased † 1  14/272 (5.15%)  18 18/264 (6.82%)  28 18/238 (7.56%)  35
Alkaline phosphatase † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 1/238 (0.42%)  1
Alkaline phosphatase increased † 1  11/272 (4.04%)  31 11/264 (4.17%)  27 18/238 (7.56%)  31
Aspartate aminotransferase increased † 1  15/272 (5.51%)  21 18/264 (6.82%)  31 17/238 (7.14%)  39
Blood bilirubin increased † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 4/238 (1.68%)  6
Creatinine increased † 1  9/272 (3.31%)  16 4/264 (1.52%)  7 2/238 (0.84%)  14
Electrocardiogram QTc interval prolonged † 1  0/272 (0.00%)  0 1/264 (0.38%)  3 0/238 (0.00%)  0
Gamma-glutamyltransferase increased † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  3
INR increased † 1  2/272 (0.74%)  3 3/264 (1.14%)  6 0/238 (0.00%)  0
Laboratory test abnormal † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 6/238 (2.52%)  9
Leukocyte count decreased † 1  55/272 (20.22%)  188 87/264 (32.95%)  242 41/238 (17.23%)  98
Lymphocyte count decreased † 1  7/272 (2.57%)  26 10/264 (3.79%)  27 5/238 (2.10%)  13
Neutrophil count decreased † 1  116/272 (42.65%)  447 178/264 (67.42%)  650 64/238 (26.89%)  144
Platelet count decreased † 1  23/272 (8.46%)  50 28/264 (10.61%)  65 16/238 (6.72%)  44
Serum cholesterol increased † 1  2/272 (0.74%)  2 0/264 (0.00%)  0 1/238 (0.42%)  1
Weight gain † 1  3/272 (1.10%)  9 0/264 (0.00%)  0 3/238 (1.26%)  6
Weight loss † 1  11/272 (4.04%)  19 13/264 (4.92%)  35 14/238 (5.88%)  31
Metabolism and nutrition disorders       
Anorexia † 1  24/272 (8.82%)  50 25/264 (9.47%)  48 30/238 (12.61%)  61
Blood bicarbonate decreased † 1  1/272 (0.37%)  2 3/264 (1.14%)  7 1/238 (0.42%)  6
Blood glucose increased † 1  32/272 (11.76%)  129 29/264 (10.98%)  64 29/238 (12.18%)  64
Dehydration † 1  6/272 (2.21%)  6 7/264 (2.65%)  9 6/238 (2.52%)  6
Serum albumin decreased † 1  10/272 (3.68%)  17 8/264 (3.03%)  19 11/238 (4.62%)  23
Serum calcium decreased † 1  9/272 (3.31%)  18 8/264 (3.03%)  12 10/238 (4.20%)  16
Serum calcium increased † 1  3/272 (1.10%)  3 2/264 (0.76%)  2 1/238 (0.42%)  1
Serum glucose decreased † 1  1/272 (0.37%)  1 3/264 (1.14%)  4 2/238 (0.84%)  2
Serum magnesium decreased † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 0/238 (0.00%)  0
Serum magnesium increased † 1  1/272 (0.37%)  2 2/264 (0.76%)  2 0/238 (0.00%)  0
Serum phosphate decreased † 1  2/272 (0.74%)  2 1/264 (0.38%)  1 1/238 (0.42%)  1
Serum potassium decreased † 1  11/272 (4.04%)  21 9/264 (3.41%)  15 12/238 (5.04%)  21
Serum potassium increased † 1  4/272 (1.47%)  15 3/264 (1.14%)  3 1/238 (0.42%)  1
Serum sodium decreased † 1  11/272 (4.04%)  33 10/264 (3.79%)  19 14/238 (5.88%)  25
Serum sodium increased † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 0/238 (0.00%)  0
Serum triglycerides increased † 1  3/272 (1.10%)  3 0/264 (0.00%)  0 0/238 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia † 1  42/272 (15.44%)  122 38/264 (14.39%)  75 37/238 (15.55%)  117
Arthritis † 1  2/272 (0.74%)  2 2/264 (0.76%)  2 1/238 (0.42%)  1
Back pain † 1  16/272 (5.88%)  28 12/264 (4.55%)  33 26/238 (10.92%)  51
Bone pain † 1  20/272 (7.35%)  41 11/264 (4.17%)  21 13/238 (5.46%)  30
Buttock pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Chest wall pain † 1  4/272 (1.47%)  5 3/264 (1.14%)  5 2/238 (0.84%)  2
Fibrosis † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Joint range of motion decreased cervical spine † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Muscle weakness † 1  2/272 (0.74%)  9 9/264 (3.41%)  19 3/238 (1.26%)  6
Muscle weakness lower limb † 1  3/272 (1.10%)  5 1/264 (0.38%)  1 2/238 (0.84%)  2
Musculoskeletal disorder † 1  3/272 (1.10%)  9 1/264 (0.38%)  2 4/238 (1.68%)  6
Myalgia † 1  92/272 (33.82%)  336 99/264 (37.50%)  295 77/238 (32.35%)  210
Neck pain † 1  6/272 (2.21%)  7 1/264 (0.38%)  3 3/238 (1.26%)  4
Osteonecrosis † 1  3/272 (1.10%)  7 0/264 (0.00%)  0 1/238 (0.42%)  1
Osteoporosis † 1  1/272 (0.37%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Pain in extremity † 1  17/272 (6.25%)  27 9/264 (3.41%)  12 11/238 (4.62%)  21
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Tumor pain † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Nervous system disorders       
Ataxia † 1  0/272 (0.00%)  0 3/264 (1.14%)  4 2/238 (0.84%)  2
Cognitive disturbance † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 1/238 (0.42%)  2
Depressed level of consciousness † 1  2/272 (0.74%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Dizziness † 1  13/272 (4.78%)  20 11/264 (4.17%)  14 15/238 (6.30%)  27
Dysgeusia † 1  12/272 (4.41%)  61 15/264 (5.68%)  40 29/238 (12.18%)  59
Encephalopathy † 1  1/272 (0.37%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Extrapyramidal disorder † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Headache † 1  20/272 (7.35%)  28 22/264 (8.33%)  43 30/238 (12.61%)  50
Intracranial hemorrhage † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Ischemia cerebrovascular † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Memory impairment † 1  2/272 (0.74%)  4 3/264 (1.14%)  3 1/238 (0.42%)  1
Mini mental status examination abnormal † 1  2/272 (0.74%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Neuralgia † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 3/238 (1.26%)  5
Neurological disorder NOS † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Peripheral motor neuropathy † 1  46/272 (16.91%)  110 66/264 (25.00%)  208 47/238 (19.75%)  204
Peripheral sensory neuropathy † 1  216/272 (79.41%)  1533 206/264 (78.03%)  1320 175/238 (73.53%)  1043
Radiculitis brachial † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Seizure † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Speech disorder † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 1/238 (0.42%)  1
Syncope † 1  5/272 (1.84%)  5 1/264 (0.38%)  1 4/238 (1.68%)  4
Syncope vasovagal † 1  1/272 (0.37%)  1 1/264 (0.38%)  1 1/238 (0.42%)  1
Tremor † 1  0/272 (0.00%)  0 1/264 (0.38%)  2 0/238 (0.00%)  0
Psychiatric disorders       
Agitation † 1  2/272 (0.74%)  3 0/264 (0.00%)  0 0/238 (0.00%)  0
Anxiety † 1  16/272 (5.88%)  29 7/264 (2.65%)  11 10/238 (4.20%)  19
Confusion † 1  2/272 (0.74%)  4 2/264 (0.76%)  2 1/238 (0.42%)  1
Depression † 1  13/272 (4.78%)  33 14/264 (5.30%)  20 14/238 (5.88%)  33
Euphoria † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Insomnia † 1  18/272 (6.62%)  41 13/264 (4.92%)  25 19/238 (7.98%)  35
Libido decreased † 1  1/272 (0.37%)  4 1/264 (0.38%)  1 1/238 (0.42%)  8
Psychosis † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Renal and urinary disorders       
Bladder hemorrhage † 1  2/272 (0.74%)  5 0/264 (0.00%)  0 1/238 (0.42%)  1
Bladder pain † 1  0/272 (0.00%)  0 1/264 (0.38%)  2 1/238 (0.42%)  2
Cystitis † 1  3/272 (1.10%)  4 1/264 (0.38%)  1 0/238 (0.00%)  0
Glomerular filtration rate decreased † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Hematuria (in the absence of vaginal bleeding) † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Hemoglobin urine positive † 1  2/272 (0.74%)  2 2/264 (0.76%)  2 1/238 (0.42%)  1
Hemorrhage urinary tract † 1  3/272 (1.10%)  5 3/264 (1.14%)  4 2/238 (0.84%)  3
Kidney pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Proteinuria † 1  58/272 (21.32%)  211 64/264 (24.24%)  188 50/238 (21.01%)  125
Ureteric hemorrhage † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Ureteric obstruction † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Ureteric stenosis † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Urethral hemorrhage † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Urethral pain † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Urinary frequency † 1  4/272 (1.47%)  7 0/264 (0.00%)  0 0/238 (0.00%)  0
Urinary incontinence † 1  5/272 (1.84%)  6 0/264 (0.00%)  0 0/238 (0.00%)  0
Urinary retention † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Urogenital disorder † 1  2/272 (0.74%)  2 3/264 (1.14%)  5 0/238 (0.00%)  0
Reproductive system and breast disorders       
Breast pain † 1  1/272 (0.37%)  1 2/264 (0.76%)  4 2/238 (0.84%)  3
Irregular menstruation † 1  2/272 (0.74%)  7 0/264 (0.00%)  0 0/238 (0.00%)  0
Ovulation pain † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Pelvic pain † 1  3/272 (1.10%)  4 1/264 (0.38%)  1 2/238 (0.84%)  6
Perineal pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Vaginal discharge † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  5
Vaginal dryness † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  3
Vaginal hemorrhage † 1  2/272 (0.74%)  2 5/264 (1.89%)  5 2/238 (0.84%)  5
Vaginal pain † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Allergic rhinitis † 1  8/272 (2.94%)  14 7/264 (2.65%)  10 14/238 (5.88%)  22
Aspiration † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 2/238 (0.84%)  5
Bronchospasm † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Cough † 1  26/272 (9.56%)  65 20/264 (7.58%)  43 24/238 (10.08%)  54
Dyspnea † 1  27/272 (9.93%)  62 29/264 (10.98%)  61 36/238 (15.13%)  91
Epistaxis † 1  68/272 (25.00%)  174 56/264 (21.21%)  185 47/238 (19.75%)  112
Hiccups † 1  0/272 (0.00%)  0 2/264 (0.76%)  3 1/238 (0.42%)  1
Hypoxia † 1  0/272 (0.00%)  0 2/264 (0.76%)  9 2/238 (0.84%)  2
Laryngeal mucositis † 1  0/272 (0.00%)  0 1/264 (0.38%)  3 0/238 (0.00%)  0
Laryngoscopy abnormal † 1  5/272 (1.84%)  7 9/264 (3.41%)  19 5/238 (2.10%)  6
Nasal congestion † 1  5/272 (1.84%)  9 5/264 (1.89%)  9 5/238 (2.10%)  12
Pharyngeal mucositis † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 2/238 (0.84%)  3
Pharyngolaryngeal pain † 1  2/272 (0.74%)  2 5/264 (1.89%)  7 4/238 (1.68%)  9
Pleural effusion † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 2/238 (0.84%)  2
Pneumonitis † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 1/238 (0.42%)  2
Pulmonary hemorrhage † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Respiratory disorder † 1  4/272 (1.47%)  10 7/264 (2.65%)  9 6/238 (2.52%)  8
Respiratory tract hemorrhage † 1  3/272 (1.10%)  3 1/264 (0.38%)  1 0/238 (0.00%)  0
Tracheal fistula † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Voice alteration † 1  5/272 (1.84%)  11 3/264 (1.14%)  7 6/238 (2.52%)  14
Skin and subcutaneous tissue disorders       
Alopecia † 1  35/272 (12.87%)  151 26/264 (9.85%)  65 40/238 (16.81%)  116
Chest wall necrosis † 1  0/272 (0.00%)  0 1/264 (0.38%)  1 0/238 (0.00%)  0
Decubitus ulcer † 1  3/272 (1.10%)  4 0/264 (0.00%)  0 0/238 (0.00%)  0
Dry skin † 1  3/272 (1.10%)  3 4/264 (1.52%)  7 7/238 (2.94%)  10
Erythema multiforme † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 0/238 (0.00%)  0
Hand-and-foot syndrome † 1  5/272 (1.84%)  16 7/264 (2.65%)  15 2/238 (0.84%)  3
Nail disorder † 1  32/272 (11.76%)  96 24/264 (9.09%)  63 16/238 (6.72%)  28
Pain of skin † 1  1/272 (0.37%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Petechiae † 1  1/272 (0.37%)  1 1/264 (0.38%)  2 0/238 (0.00%)  0
Photosensitivity † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 0/238 (0.00%)  0
Pruritus † 1  8/272 (2.94%)  9 8/264 (3.03%)  19 4/238 (1.68%)  17
Rash acneiform † 1  1/272 (0.37%)  1 7/264 (2.65%)  11 3/238 (1.26%)  6
Rash desquamating † 1  17/272 (6.25%)  28 34/264 (12.88%)  71 14/238 (5.88%)  33
Scalp pain † 1  2/272 (0.74%)  3 0/264 (0.00%)  0 0/238 (0.00%)  0
Skin disorder † 1  11/272 (4.04%)  17 5/264 (1.89%)  6 1/238 (0.42%)  1
Skin hyperpigmentation † 1  3/272 (1.10%)  15 4/264 (1.52%)  10 1/238 (0.42%)  3
Skin ulceration † 1  3/272 (1.10%)  6 2/264 (0.76%)  4 2/238 (0.84%)  4
Sweating † 1  3/272 (1.10%)  3 3/264 (1.14%)  8 1/238 (0.42%)  1
Urticaria † 1  1/272 (0.37%)  1 0/264 (0.00%)  0 0/238 (0.00%)  0
Vascular disorders       
Flushing † 1  1/272 (0.37%)  1 2/264 (0.76%)  2 1/238 (0.42%)  1
Hematoma † 1  2/272 (0.74%)  2 0/264 (0.00%)  0 0/238 (0.00%)  0
Hemorrhage † 1  3/272 (1.10%)  4 3/264 (1.14%)  3 2/238 (0.84%)  2
Hot flashes † 1  5/272 (1.84%)  15 9/264 (3.41%)  12 10/238 (4.20%)  25
Hypertension † 1  127/272 (46.69%)  596 97/264 (36.74%)  418 90/238 (37.82%)  345
Hypotension † 1  1/272 (0.37%)  1 4/264 (1.52%)  4 5/238 (2.10%)  6
Lymphedema † 1  0/272 (0.00%)  0 0/264 (0.00%)  0 1/238 (0.42%)  1
Phlebitis † 1  1/272 (0.37%)  18 0/264 (0.00%)  0 0/238 (0.00%)  0
Thrombosis † 1  7/272 (2.57%)  30 8/264 (3.03%)  13 3/238 (1.26%)  3
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Hope Rugo, M.D.
Organization: UCSF Comprehensive Cancer Center
EMail: hrugo@medicine.ucsf.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00785291    
Other Study ID Numbers: NCI-2009-00476
NCI-2009-00476 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CTSU 40502
CDR0000617539
NCCTG N063H
CALGB-40502
PCALGB-40502_A11PAMDREVW01
CALGB 40502 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-40502 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: November 4, 2008
First Posted: November 5, 2008
Results First Submitted: June 5, 2015
Results First Posted: July 2, 2015
Last Update Posted: February 9, 2021