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Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal 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: NCT00951496
Recruitment Status : Active, not recruiting
First Posted : August 4, 2009
Results First Posted : May 18, 2018
Last Update Posted : November 8, 2019
Sponsor:
Collaborator:
NRG Oncology
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 Ovarian Brenner Tumor
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Cystadenocarcinoma
Ovarian Seromucinous Carcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Carcinoma
Stage IIA Fallopian Tube Cancer AJCC v6 and v7
Stage IIA Ovarian Cancer AJCC V6 and v7
Stage IIB Fallopian Tube Cancer AJCC v6 and v7
Stage IIB Ovarian Cancer AJCC v6 and v7
Stage IIC Fallopian Tube Cancer AJCC v6 and v7
Stage IIC Ovarian Cancer AJCC v6 and v7
Stage IIIA Fallopian Tube Cancer AJCC v7
Stage IIIA Ovarian Cancer AJCC v6 and v7
Stage IIIA Primary Peritoneal Cancer AJCC v7
Stage IIIB Fallopian Tube Cancer AJCC v7
Stage IIIB Ovarian Cancer AJCC v6 and v7
Stage IIIB Primary Peritoneal Cancer AJCC v7
Stage IIIC Fallopian Tube Cancer AJCC v7
Stage IIIC Ovarian Cancer AJCC v6 and v7
Stage IIIC Primary Peritoneal Cancer AJCC v7
Interventions Biological: Bevacizumab
Drug: Carboplatin
Drug: Cisplatin
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Quality-of-Life Assessment
Enrollment 1560
Recruitment Details The study was opened for accrual on July 27, 2009. Target accrual was about 1500 patients. The study was closed to enrollment on Nov 30, 2011 after enrolling 1560 individuals.
Pre-assignment Details Eligibility was verified by a web-based procedure which reviewed all eligibility criteria prior to each subject’s registration. Prior to treatment randomization patients were stratified by stage of disease and size of residual disease.
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Hide Arm/Group Description Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22. Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22 Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
Period Title: Overall Study
Started 521 518 521
Completed 511 510 508
Not Completed 10 8 13
Reason Not Completed
Did not initiate study treatment             10             8             13
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) Arm III (Paclitaxel IP, Cisplatin, Bevacizumab) Total
Hide Arm/Group Description Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22. Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22 Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22. Total of all reporting groups
Overall Number of Baseline Participants 521 518 521 1560
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 518 participants 521 participants 1560 participants
<40 years
27
   5.2%
13
   2.5%
18
   3.5%
58
   3.7%
40 - 49 years
101
  19.4%
77
  14.9%
95
  18.2%
273
  17.5%
50 - 59 years
187
  35.9%
178
  34.4%
199
  38.2%
564
  36.2%
60 -69 years
152
  29.2%
181
  34.9%
151
  29.0%
484
  31.0%
70 - 79 years
51
   9.8%
64
  12.4%
53
  10.2%
168
  10.8%
>79 years
3
   0.6%
5
   1.0%
5
   1.0%
13
   0.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 518 participants 521 participants 1560 participants
Female
521
 100.0%
518
 100.0%
521
 100.0%
1560
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 518 participants 521 participants 1560 participants
American Indian or Alaska Native
2
   0.4%
2
   0.4%
2
   0.4%
6
   0.4%
Asian
15
   2.9%
15
   2.9%
17
   3.3%
47
   3.0%
Native Hawaiian or Other Pacific Islander
1
   0.2%
1
   0.2%
0
   0.0%
2
   0.1%
Black or African American
17
   3.3%
17
   3.3%
17
   3.3%
51
   3.3%
White
473
  90.8%
478
  92.3%
476
  91.4%
1427
  91.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
13
   2.5%
5
   1.0%
9
   1.7%
27
   1.7%
FIGO Stage FIGO (International Federation of Gynecology & Obstetrics) Staging   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 518 participants 521 participants 1560 participants
Stage I-II
56
  10.7%
56
  10.8%
51
   9.8%
163
  10.4%
Stage III
441
  84.6%
432
  83.4%
432
  82.9%
1305
  83.7%
Stage IV
24
   4.6%
30
   5.8%
38
   7.3%
92
   5.9%
[1]
Measure Description: FIGO staging of the Ovary was used. FIGO stage I includes all participants with disease confined to ovary. This stage has the best outcome, between 75 to 90% survival at 5 years. Stage II includes all participants with disease in ovaries and spread limited to pelvis (45 to 60% survival at 5 years). Stage III includes all participants with disease limited to abdomen. Stage IV disease includes all participants with distant metastasis outside the abdominal cavity. This stage has the worst outcome (<20% survival at 5 years)
Residual Disease Diameter  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 518 participants 521 participants 1560 participants
Microscopic only
297
  57.0%
297
  57.3%
305
  58.5%
899
  57.6%
0 < diameter <= 1cm
182
  34.9%
189
  36.5%
182
  34.9%
553
  35.4%
> 1cm
42
   8.1%
32
   6.2%
34
   6.5%
108
   6.9%
Histology/Grade of tumor   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 521 participants 518 participants 521 participants 1560 participants
Serous/Grade1
20
   3.8%
12
   2.3%
27
   5.2%
59
   3.8%
Serous/Grade 2
43
   8.3%
36
   6.9%
35
   6.7%
114
   7.3%
Serous/Grade 3
370
  71.0%
379
  73.2%
377
  72.4%
1126
  72.2%
Endometrioid
5
   1.0%
2
   0.4%
4
   0.8%
11
   0.7%
Clear Cell
32
   6.1%
29
   5.6%
26
   5.0%
87
   5.6%
Mucinous
2
   0.4%
5
   1.0%
5
   1.0%
12
   0.8%
Other/Not specified
48
   9.2%
55
  10.6%
47
   9.0%
150
   9.6%
[1]
Measure Description: The Histology/Grade lists how many participants entered the study with each type of tumor histology and the grade for the serous tumors. Histology is the type of tissue that the tumor is comprised of. The histologic types listed below include serous, endometrioid, clear cell, mucinous and other or not specified. Grading refers to (along with staging) describes the severity. Grade 1 tumor cells look a lot like normal ovarian cells. The outcome is good for grade I tumors. Grade 2 tumors are well differentiated. Grade 3 cells are more irregular and likely to metastasize.
1.Primary Outcome
Title Median Progression-free Survival
Hide Description Estimate the median duration of progression-free survival in months. Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat: All enrolled patients
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Hide Arm/Group Description:
Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
Overall Number of Participants Analyzed 521 518 521
Median (95% Confidence Interval)
Unit of Measure: months
24.9
(22.3 to 27.2)
27.3
(24.6 to 28.8)
26.0
(23.8 to 28.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Paclitaxel, Carboplatin, Bevcizumab IV), Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
Comments P value.(an P value is used to determine statistical significance in a hypothesis test). from a stratified log rank test to assess equality of progression free survival hazards of arm II and arm I
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Study was designed to provide 80% power when arm II reduces the progression free survival event rate 20%. The critical p-value accounts for correlation between 2 primary hypotheses.
Statistical Test of Hypothesis P-Value 0.341
Comments P value not adjusted for multiplicity. Significance Threshold = 0.027
Method Log Rank
Comments Stratified by stage of disease and size of residual disease.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.94
Confidence Interval (2-Sided) 95%
0.81 to 1.09
Estimation Comments Progression free survival of arm II relative to arm I. Adjusted for stage of disease and residual size.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Paclitaxel, Carboplatin, Bevcizumab IV), Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Comments P value from a log rank test comparing the progression free survival hazards of arm III to arm I.
Type of Statistical Test Non-Inferiority or Equivalence (legacy)
Comments Study was designed to provide 80% power when arm III reduced the true progression free survival event rate. 20% compared to arm I. Critical p value accounts for correlation between 2 primary hypotheses.
Statistical Test of Hypothesis P-Value 0.587
Comments P value not adjusted for multiplicity. Significance threshold = 0.027 accounting for 2 correlated primary hypotheses.
Method Log Rank
Comments Stratified by stage of disease and size of residual disease.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.86 to 1.15
Estimation Comments Progression free survival hazard of arm III to arm I. Adjusted for stage of disease and residual disease size.
2.Secondary Outcome
Title Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0
Hide Description Eligible and treated patients. CTCAE includes grades 1-5. Grade refers to the severity of the adverse event. Grades 0 listed should be interpreted to mean there were no subjects in the arm with a toxicity to report. Grade 1 toxicities are mild; asymptomatic or mild symptoms. Grade 2 toxicities are moderate; minimal, local or noninvasive intervention indicated. Grade 3 toxicities are severe or medically significant but not immediately life-threatening. Grade 4 toxicities are life threatening. Grade 5 is death related to adverse event.
Time Frame During treatment and up to 30 days after end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Patients
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Hide Arm/Group Description:
Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
Overall Number of Participants Analyzed 521 518 521
Measure Type: Count of Participants
Unit of Measure: Participants
Adverse Event Grade 0
0
   0.0%
0
   0.0%
1
   0.2%
Adverse Event Grade 1
1
   0.2%
0
   0.0%
0
   0.0%
Adverse Event Grade 2
48
   9.2%
46
   8.9%
52
  10.0%
Adverse Event Grade 3
269
  51.6%
300
  57.9%
246
  47.2%
Adverse Event Grade 4
185
  35.5%
158
  30.5%
199
  38.2%
Adverse Event Grade 5
8
   1.5%
6
   1.2%
10
   1.9%
3.Secondary Outcome
Title Overall Survival
Hide Description Estimate the median duration of overall survival in months.
Time Frame Up to 10 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat: All enrolled patients
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Bevacizumab) Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.

Bevacizumab: Given IV

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.

Bevacizumab: Given IV

Carboplatin: Given IP

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.

Bevacizumab: Given IV

Cisplatin: Given IP

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Paclitaxel: Given IP

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 521 518 521
Median (95% Confidence Interval)
Unit of Measure: Months
75.4 [1] 
(67.1 to NA)
74.2
(61.9 to 78.4)
67.6
(63.5 to 74.6)
[1]
Not defined because there are insufficient number of participant with event.
4.Secondary Outcome
Title Patient Reported Quality of Life (QOL)
Hide Description QOL was measured with the FACT-O TOI score. Means at baseline are raw means. Scores are reported at all time points in the outcome measure table. FACT-O TOI is Trial outcome index (TOI) of the Functional assessment of cancer therapy (FACT) for ovarian cancer (FACT-O). The FACT-O TOI is composed of three subscales; Physical Well Being (PWB) ( 7 items), and Ovarian Cancer subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much). A subscale score is computed as long as more thatn 50% of subscale items have been answered. A total score of the FACT-O items provide valid responses and all three subscales have valid scores. A score of the FACT-) TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL).
Time Frame Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients evaluable for PRO (Patient Reported Outcomes)/QOL (completed baseline and at least one follow-up assessment)
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Bevacizumab) Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.

Bevacizumab: Given IV

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.

Bevacizumab: Given IV

Carboplatin: Given IP

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.

Bevacizumab: Given IV

Cisplatin: Given IP

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Paclitaxel: Given IP

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 492 481 464
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Baseline 68.5  (0.7) 67.4  (0.7) 67.7  (0.7)
Prior to cycle 4 67.8  (0.6) 65.6  (0.6) 61.9  (0.6)
Prior to cycle 7 69.1  (0.6) 68.2  (0.6) 65.7  (0.7)
Prior to cycle 13 77.3  (0.6) 77.1  (0.6) 78.4  (0.6)
Prior to cycle 21 77.7  (0.6) 76.9  (0.7) 78.2  (0.6)
84 weeks 78.3  (0.7) 77.7  (0.7) 79.4  (0.7)
5.Secondary Outcome
Title Patient Reported Neurotoxicity (Ntx)
Hide Description The FACT/GOG-NTX subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5 point Likert scale (0=not at all; 1=a little bit;2=somewhat;3=quite a bit; 4=very much). For each item, reversal was performed prior to score calculation so that a large score suggests less symptoms. According to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of a subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges from 0-16 with a large subscale score suggesting less symptom or better QOL.
Time Frame Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients evaluable for PRO(Patient Reported Outcome)/QOL (completed baseline and at least one follow-up assessment).
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Bevacizumab) Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.

Bevacizumab: Given IV

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.

Bevacizumab: Given IV

Carboplatin: Given IP

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.

Bevacizumab: Given IV

Cisplatin: Given IP

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Paclitaxel: Given IP

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 492 481 464
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
Baseline 15.4  (0.1) 15.4  (0.1) 15.4  (0.1)
Prior to cycle 4 12.9  (0.2) 13.0  (0.2) 13.6  (0.2)
Prior to cycle 7 10.4  (0.2) 10.3  (0.2) 10.9  (0.2)
Prior to cycle 13 11.1  (0.2) 10.5  (0.2) 9.2  (0.2)
Prior to cycle 21 11.4  (0.2) 11.1  (0.2) 11.0  (0.2)
84 weeks 11.9  (0.2) 11.4  (0.2) 11.5  (0.2)
6.Secondary Outcome
Title Patient Reported Fatigue
Hide Description Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggesting less fatigue.
Time Frame Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients evaluable for PRO (Patient Reported Outcomes)/QOL. Evaluable patients have completed baseline and at least one follow-up assessment.
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Bevacizumab) Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.

Bevacizumab: Given IV

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.

Bevacizumab: Given IV

Carboplatin: Given IP

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.

Bevacizumab: Given IV

Cisplatin: Given IP

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Paclitaxel: Given IP

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 492 481 464
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 35.3  (0.3) 35.1  (0.3) 35.3  (0.3)
Prior to cycle 4 32.5  (0.3) 32.0  (0.3) 31.3  (0.3)
Prior to cycle 7 32.7  (0.3) 32.7  (0.3) 32.4  (0.3)
Prior to cycle 13 35.7  (0.3) 35.5  (0.3) 35.9  (0.3)
Prior to cycle 21 35.5  (0.3) 35.1  (0.3) 36.3  (0.3)
84 weeks 35.7  (0.3) 36.0  (0.3) 36.5  (0.3)
7.Secondary Outcome
Title Patient Reported Nausea
Hide Description Nausea was measured with the a single item ,' I have nausea' from the FACT-O TOI, and was scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much)
Time Frame Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients evaluable for PRO (Patient Reported Outcomes)/QOL are patients who completed baseline and at least one follow-up assessment
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Bevacizumab) Arm II (Paclitaxel, Bevacizumab, Carboplatin IP) Arm III (Paclitaxel IP, Bevacizumab, Cisplatin IP)
Hide Arm/Group Description:

Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and carboplatin IV over 30 minutes on day 1. Patients also receive bevacizumab IV over 30-90 minutes on day 1 in courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone in courses 7-22 in the absence of disease progression or unacceptable toxicity.

Bevacizumab: Given IV

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel as in Arm I and carboplatin IP on day 1. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.

Bevacizumab: Given IV

Carboplatin: Given IP

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours on day 1, cisplatin IP on day 2, and paclitaxel IP on day 8. Patients also receive bevacizumab as in Arm I. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab alone as in Arm I.

Bevacizumab: Given IV

Cisplatin: Given IP

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Paclitaxel: Given IP

Quality-of-Life Assessment: Ancillary studies

Overall Number of Participants Analyzed 492 481 464
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Baseline 0.4  (0.04) 0.4  (0.04) 0.4  (0.04)
Prior to cycle 4 0.6  (0.04) 0.7  (0.04) 1.1  (0.05)
Prior to cycle 7 0.5  (0.04) 0.5  (0.04) 0.7  (0.05)
Prior to cycle 13 0.2  (0.03) 0.3  (0.03) 0.2  (0.03)
Prior to cycle 21 0.3  (0.04) 0.4  (0.04) 0.3  (0.03)
84 Weeks 0.3  (0.04) 0.4  (0.04) 0.3  (0.03)
Time Frame AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Hide Arm/Group Description Six cycles of Paclitaxel 80mg/m2 IV over ` hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22. Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22 Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
All-Cause Mortality
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   156/511 (30.53%)   179/510 (35.10%)   215/508 (42.32%) 
Blood and lymphatic system disorders       
Neutrophils * 1  10/511 (1.96%)  6/510 (1.18%)  4/508 (0.79%) 
Platelets * 1  2/511 (0.39%)  1/510 (0.20%)  0/508 (0.00%) 
Blood/Bone Marrow - Other * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Leukocytes * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Hemoglobin * 1  1/511 (0.20%)  2/510 (0.39%)  0/508 (0.00%) 
Lymphocele * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Cardiac disorders       
Sinus/Node (S/N) Arrhythmia: Atrial Fibrillation * 1  2/511 (0.39%)  2/510 (0.39%)  3/508 (0.59%) 
S/N Arrhythmia: Sinus Tachycardia * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Supraventricular Tachycardia * 1  0/511 (0.00%)  0/510 (0.00%)  2/508 (0.39%) 
Cardiac Ischemia/Infarction * 1  2/511 (0.39%)  4/510 (0.78%)  1/508 (0.20%) 
Right Ventricular Dysfunction * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Hypertension * 1  4/511 (0.78%)  5/510 (0.98%)  12/508 (2.36%) 
Restrictive Cardiomyopathy * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Left Venticular Diastolic Dysfunction * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Left Ventricular Systolic Dysfunction * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Cardiac General - Other * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Pericarditis * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Endocrine disorders       
Hypothyroidism * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Eye disorders       
Blurred Vision * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Gastrointestinal disorders       
Fistula, Gi - Colon/Cecum/Appendix * 1  1/511 (0.20%)  1/510 (0.20%)  2/508 (0.39%) 
Enteritis * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Perforation, Gastrointestinal (GI) - Duodenum * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Perforation, Gi - Appendix * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Obstruction, Gi - Ileum * 1  0/511 (0.00%)  2/510 (0.39%)  0/508 (0.00%) 
Necrosis, Gi - Small Bowel Nos * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Perforation, Gi - Colon * 1  5/511 (0.98%)  2/510 (0.39%)  4/508 (0.79%) 
Fistula, Gi - Small Bowel Nos * 1  1/511 (0.20%)  3/510 (0.59%)  2/508 (0.39%) 
Fistula, Gi - Rectum * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
Obstruction, Gi - Colon * 1  1/511 (0.20%)  1/510 (0.20%)  2/508 (0.39%) 
Esophagitis * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Leak, Gi - Large Bowel * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Leak, Gi - Leak Nos * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Fistula, Gi - Anus * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Ileus * 1  2/511 (0.39%)  3/510 (0.59%)  4/508 (0.79%) 
Dysphagia * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Distention * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Fistula, Gi - Abdomen Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Obstruction, Gi - Gallbladder * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Mucositis (Functional/Sympt) - Oral Cavity * 1  0/511 (0.00%)  0/510 (0.00%)  2/508 (0.39%) 
Obstruction, Gi - Duodenal * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Obstruction, Gi - Small Bowel Nos * 1  17/511 (3.33%)  20/510 (3.92%)  12/508 (2.36%) 
Colitis * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Obstruction, Gi - Jejunum * 1  3/511 (0.59%)  0/510 (0.00%)  0/508 (0.00%) 
Perforation, Gi - Small Bowel Nos * 1  1/511 (0.20%)  2/510 (0.39%)  4/508 (0.79%) 
Vomiting * 1  2/511 (0.39%)  2/510 (0.39%)  13/508 (2.56%) 
Dehydration * 1  1/511 (0.20%)  7/510 (1.37%)  9/508 (1.77%) 
Constipation * 1  2/511 (0.39%)  1/510 (0.20%)  6/508 (1.18%) 
Nausea * 1  1/511 (0.20%)  3/510 (0.59%)  5/508 (0.98%) 
Gastrointestinal - Other * 1  0/511 (0.00%)  2/510 (0.39%)  3/508 (0.59%) 
Perforation, Gi - Ileum * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Diarrhea * 1  2/511 (0.39%)  3/510 (0.59%)  5/508 (0.98%) 
General disorders       
Fever * 1  1/511 (0.20%)  2/510 (0.39%)  4/508 (0.79%) 
Weight Loss * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Rigors/Chills * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Fatigue * 1  2/511 (0.39%)  2/510 (0.39%)  1/508 (0.20%) 
Death No Ctcae Term - Disease Progression Not otherwise specified (NOS) * 1  2/511 (0.39%)  0/510 (0.00%)  1/508 (0.20%) 
Death No Ctcae Term - Death Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Death No Ctcae Term - Multi-Organ Failure * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Death No Ctcae Term - Sudden Death * 1  0/511 (0.00%)  0/510 (0.00%)  3/508 (0.59%) 
Pain - Other * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Pain: Chest /Thorax Nos * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Pain: Head/Headache * 1  1/511 (0.20%)  1/510 (0.20%)  2/508 (0.39%) 
Pain: Neck * 1  0/511 (0.00%)  0/510 (0.00%)  2/508 (0.39%) 
Pain: Joint * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Pain: Bladder * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Pain: Oral Cavity * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Pain: Esophagus * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Pain: Abdominal Pain Nos * 1  6/511 (1.17%)  13/510 (2.55%)  12/508 (2.36%) 
Pain: Cardiac/ Heart * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Syndromes - Other * 1  0/511 (0.00%)  1/510 (0.20%)  3/508 (0.59%) 
Hepatobiliary disorders       
Hepatobiliary/Pancreas - Other * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Cholecystitis * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Pancreatitis * 1  0/511 (0.00%)  0/510 (0.00%)  3/508 (0.59%) 
Immune system disorders       
Allergic Reaction/Hypersensitivity * 1  2/511 (0.39%)  2/510 (0.39%)  2/508 (0.39%) 
Infections and infestations       
Infection (Inf) with Grade 3 Or 4 Absolute Neutrophil Count (Anc): Wound * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Blood * 1  2/511 (0.39%)  1/510 (0.20%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Colon * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Anal/Perianal * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Mediastinum Nos * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) * 1  3/511 (0.59%)  2/510 (0.39%)  3/508 (0.59%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Gallbladder * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  0/511 (0.00%)  2/510 (0.39%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  2/511 (0.39%)  4/510 (0.78%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Appendix * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) * 1  3/511 (0.59%)  1/510 (0.20%)  5/508 (0.98%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related * 1  2/511 (0.39%)  3/510 (0.59%)  7/508 (1.38%) 
Febrile Neutropenia * 1  6/511 (1.17%)  4/510 (0.78%)  7/508 (1.38%) 
Inf Unknown Anc: Lung (Pneumonia) * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Colon * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  1/511 (0.20%)  4/510 (0.78%)  2/508 (0.39%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos * 1  0/511 (0.00%)  3/510 (0.59%)  3/508 (0.59%) 
Inf Unknown Anc: Blood * 1  1/511 (0.20%)  1/510 (0.20%)  2/508 (0.39%) 
Infection - Other * 1  2/511 (0.39%)  2/510 (0.39%)  2/508 (0.39%) 
Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Colitis, Infectious (Eg.C. Difficile) * 1  0/511 (0.00%)  1/510 (0.20%)  4/508 (0.79%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Abdomen Nos * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Up. Aerodigestive * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos * 1  0/511 (0.00%)  5/510 (0.98%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Inf Unknown Anc: Catheter-Related * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Inf Unknown Anc: Rectum * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf Unknown Anc: Abdomen Nos * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf Unknown Anc: Skin (Cellulitis) * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) * 1  1/511 (0.20%)  0/510 (0.00%)  2/508 (0.39%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney * 1  2/511 (0.39%)  1/510 (0.20%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos * 1  0/511 (0.00%)  2/510 (0.39%)  2/508 (0.39%) 
Inf W/Gr 3 Or 4 Anc: Catheter-Related * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Metabolism and nutrition disorders       
Metabolic/Laboratory - Other * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Proteinuria * 1  1/511 (0.20%)  2/510 (0.39%)  1/508 (0.20%) 
Creatinine * 1  1/511 (0.20%)  1/510 (0.20%)  4/508 (0.79%) 
Alanine Aminotransferase (Alt) * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Hyponatremia * 1  0/511 (0.00%)  1/510 (0.20%)  2/508 (0.39%) 
Acidosis * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Hyperkalemia * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Hyperglycemia * 1  2/511 (0.39%)  0/510 (0.00%)  1/508 (0.20%) 
Hypokalemia * 1  0/511 (0.00%)  2/510 (0.39%)  2/508 (0.39%) 
Hypercalcemia * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Hypomagnesemia * 1  1/511 (0.20%)  1/510 (0.20%)  2/508 (0.39%) 
Musculoskeletal and connective tissue disorders       
Seroma * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Musculoskeletal/St: Other * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Device/Prosthesis * 1  0/511 (0.00%)  0/510 (0.00%)  2/508 (0.39%) 
Fracture * 1  0/511 (0.00%)  3/510 (0.59%)  3/508 (0.59%) 
Muscle Weakness - Whole Body/Generalized * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Muscle Weakness - Extremity-Upper * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
2nd Malignancy: Poss. Related To Cancer Rx * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Nervous system disorders       
Syncope * 1  5/511 (0.98%)  1/510 (0.20%)  7/508 (1.38%) 
Neurology - Other * 1  0/511 (0.00%)  1/510 (0.20%)  2/508 (0.39%) 
Encephalopathy * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Mood Alteration - Anxiety * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Tremor * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Speech Impairment * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Seizure * 1  0/511 (0.00%)  0/510 (0.00%)  4/508 (0.79%) 
Personality * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Cognitive Disturbance * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Central Nervous System (Cns) Ischemia * 1  2/511 (0.39%)  2/510 (0.39%)  4/508 (0.79%) 
Confusion * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Memory Impairment * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Dizziness * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Neuropathy-Sensory * 1  3/511 (0.59%)  2/510 (0.39%)  0/508 (0.00%) 
Renal and urinary disorders       
Renal/Genitourinary - Other * 1  3/511 (0.59%)  0/510 (0.00%)  0/508 (0.00%) 
Perforation, Gu - Vagina * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Leak, Gu - Vagina * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Urinary Color Change * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Obstruction, Gu - Ureter * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Fistula, Gu - Vagina * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Fistula, Gu - Bladder * 1  0/511 (0.00%)  2/510 (0.39%)  0/508 (0.00%) 
Renal Failure * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary: Other * 1  2/511 (0.39%)  0/510 (0.00%)  2/508 (0.39%) 
Nasal/Paranasal Reactions * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Pneumothorax * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
Hypoxia * 1  1/511 (0.20%)  0/510 (0.00%)  2/508 (0.39%) 
Pneumonitis * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Pleural Effusion * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Dyspnea * 1  5/511 (0.98%)  2/510 (0.39%)  2/508 (0.39%) 
Skin and subcutaneous tissue disorders       
Injection Site Reaction * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Wound Complication, Non-Infectious * 1  2/511 (0.39%)  7/510 (1.37%)  5/508 (0.98%) 
Vascular disorders       
International Normalized ratio (Inr) * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Hemorrhage, Genitourinary (Gu) - Urinary Nos * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Hemorrhage, Gu - Vagina * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Hemorrhage, Gi - Rectum * 1  0/511 (0.00%)  2/510 (0.39%)  1/508 (0.20%) 
Hemorrhage, Gi - Peritoneal Cavity * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Hemorrhage, Gi - Upper Gi Nos * 1  2/511 (0.39%)  0/510 (0.00%)  1/508 (0.20%) 
Hemorrhage With Surgery * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Hemorrhage/Pulmonary - Nose * 1  0/511 (0.00%)  3/510 (0.59%)  3/508 (0.59%) 
Hematoma * 1  1/511 (0.20%)  2/510 (0.39%)  1/508 (0.20%) 
Hemorrhage, Gi - Lower Gi Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Hemorrhage, Gi - Stomach * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Hemorrhage, Gi - Colon * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Hemorrhage, Cns * 1  0/511 (0.00%)  0/510 (0.00%)  3/508 (0.59%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Thrombosis/Thrombus/Embolism * 1  25/511 (4.89%)  25/510 (4.90%)  25/508 (4.92%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV) Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP) Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   511/511 (100.00%)   510/510 (100.00%)   507/508 (99.80%) 
Blood and lymphatic system disorders       
Neutrophils * 1  484/511 (94.72%)  473/510 (92.75%)  462/508 (90.94%) 
Platelets * 1  371/511 (72.60%)  370/510 (72.55%)  253/508 (49.80%) 
Blood/Bone Marrow - Other * 1  3/511 (0.59%)  1/510 (0.20%)  4/508 (0.79%) 
Leukocytes * 1  486/511 (95.11%)  480/510 (94.12%)  459/508 (90.35%) 
Lymphopenia * 1  48/511 (9.39%)  55/510 (10.78%)  44/508 (8.66%) 
Hemolysis * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Hemoglobin * 1  499/511 (97.65%)  490/510 (96.08%)  483/508 (95.08%) 
Lymphedema-Related Fibrosis * 1  1/511 (0.20%)  0/510 (0.00%)  3/508 (0.59%) 
Lymphatics - Other * 1  1/511 (0.20%)  2/510 (0.39%)  1/508 (0.20%) 
Lymphocele * 1  6/511 (1.17%)  4/510 (0.78%)  3/508 (0.59%) 
Edema: Trunk/Genital * 1  8/511 (1.57%)  4/510 (0.78%)  9/508 (1.77%) 
Edema: Limb * 1  101/511 (19.77%)  106/510 (20.78%)  94/508 (18.50%) 
Edema: Head And Neck * 1  12/511 (2.35%)  5/510 (0.98%)  10/508 (1.97%) 
Dermal Change * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Cardiac disorders       
Prolonged Q wave and tc wave Interval * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
S/N Arrhythmia: Atrial Fibrillation * 1  2/511 (0.39%)  1/510 (0.20%)  2/508 (0.39%) 
Conduction Abnml: Conduction Abnormality Nos * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Palpitations * 1  41/511 (8.02%)  25/510 (4.90%)  31/508 (6.10%) 
Cardiac Arrhythmia - Other * 1  3/511 (0.59%)  0/510 (0.00%)  0/508 (0.00%) 
Conduction Abnml: Av Block 1st Degree * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Ventricular Arrhythmia - Tachycardia * 1  5/511 (0.98%)  5/510 (0.98%)  3/508 (0.59%) 
S/N Arrhythmia: Sinus Tachycardia * 1  26/511 (5.09%)  20/510 (3.92%)  15/508 (2.95%) 
Vasovagal Episode * 1  0/511 (0.00%)  2/510 (0.39%)  4/508 (0.79%) 
Supraventricular Tachycardia * 1  3/511 (0.59%)  4/510 (0.78%)  3/508 (0.59%) 
S/N Arrhythmia: Sinus Bradycardia * 1  1/511 (0.20%)  1/510 (0.20%)  7/508 (1.38%) 
Ventricular Arrhythmia - Pvcs * 1  1/511 (0.20%)  2/510 (0.39%)  0/508 (0.00%) 
Ventricular Arrhythmia - Trigeminny * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Ventricular Arrhythmia - Bigeminy * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
S/N Arrhythmia: Atrial Tachycardia * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
Cardiac Ischemia/Infarction * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Right Ventricular Dysfunction * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Pulmonary Hypertension * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Hypertension * 1  205/511 (40.12%)  189/510 (37.06%)  242/508 (47.64%) 
Valvular Heart Disease * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
Left Venticular Diastolic Dysfunction * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Lt Ventricular Systolic Dysfunction * 1  0/511 (0.00%)  2/510 (0.39%)  1/508 (0.20%) 
Cardiac General - Other * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Cardiac Troponin I (Ctni) * 1  1/511 (0.20%)  2/510 (0.39%)  1/508 (0.20%) 
Cardiac Troponin T (Ctnt) * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Pericardial Effusion * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Hypotension * 1  15/511 (2.94%)  19/510 (3.73%)  29/508 (5.71%) 
Ear and labyrinth disorders       
Otitis Middle Ear * 1  6/511 (1.17%)  1/510 (0.20%)  1/508 (0.20%) 
Auditory/Ear - Other * 1  1/511 (0.20%)  2/510 (0.39%)  1/508 (0.20%) 
Otitis External Ear * 1  0/511 (0.00%)  2/510 (0.39%)  2/508 (0.39%) 
Hearing (Without Monitoring Program) * 1  12/511 (2.35%)  9/510 (1.76%)  21/508 (4.13%) 
Tinnitus * 1  60/511 (11.74%)  33/510 (6.47%)  59/508 (11.61%) 
Hearing (Monitoring Program) * 1  5/511 (0.98%)  2/510 (0.39%)  6/508 (1.18%) 
Endocrine disorders       
Hot Flashes * 1  103/511 (20.16%)  84/510 (16.47%)  89/508 (17.52%) 
Diabetes * 1  2/511 (0.39%)  1/510 (0.20%)  0/508 (0.00%) 
Hypoparathyroidism * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Adrenal Insufficiency * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Hyperthyroidism * 1  2/511 (0.39%)  1/510 (0.20%)  1/508 (0.20%) 
Endocrine - Other * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Hypothyroidism * 1  7/511 (1.37%)  10/510 (1.96%)  4/508 (0.79%) 
Cushingoid * 1  2/511 (0.39%)  3/510 (0.59%)  0/508 (0.00%) 
Eye disorders       
Retinopathy * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Ocular/Visual - Other * 1  9/511 (1.76%)  4/510 (0.78%)  7/508 (1.38%) 
Vitreous Hemorrhage * 1  2/511 (0.39%)  2/510 (0.39%)  1/508 (0.20%) 
Nystagmus * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Nyctalopia * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
Watery Eye * 1  26/511 (5.09%)  26/510 (5.10%)  8/508 (1.57%) 
Dry Eye * 1  16/511 (3.13%)  18/510 (3.53%)  12/508 (2.36%) 
Ocular Surface Disease * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Cataract * 1  2/511 (0.39%)  6/510 (1.18%)  1/508 (0.20%) 
Photophobia * 1  4/511 (0.78%)  3/510 (0.59%)  3/508 (0.59%) 
Flashing Lights/Floaters * 1  18/511 (3.52%)  23/510 (4.51%)  17/508 (3.35%) 
Diplopia * 1  3/511 (0.59%)  5/510 (0.98%)  3/508 (0.59%) 
Blurred Vision * 1  89/511 (17.42%)  82/510 (16.08%)  78/508 (15.35%) 
Keratitis * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Eyelid Dysfunction * 1  3/511 (0.59%)  2/510 (0.39%)  4/508 (0.79%) 
Gastrointestinal disorders       
Fistula, Gi - Colon/Cecum/Appendix * 1  0/511 (0.00%)  4/510 (0.78%)  1/508 (0.20%) 
Enteritis * 1  2/511 (0.39%)  4/510 (0.78%)  0/508 (0.00%) 
Perforation, Gi - Duodenum * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Ulcer,gi - Colon * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Obstruction, Gi - Ileum * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Proctitis * 1  3/511 (0.59%)  0/510 (0.00%)  0/508 (0.00%) 
Ulcer,gi - Anus * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Salivary Gland Changes * 1  1/511 (0.20%)  0/510 (0.00%)  6/508 (1.18%) 
Flatulence * 1  24/511 (4.70%)  22/510 (4.31%)  26/508 (5.12%) 
Perforation, Gi - Colon * 1  0/511 (0.00%)  0/510 (0.00%)  2/508 (0.39%) 
Ulcer,gi - Duodenum * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Fistula, Gi - Ileum * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Dental: Periodontal * 1  6/511 (1.17%)  6/510 (1.18%)  2/508 (0.39%) 
Fistula, Gi - Small Bowel Nos * 1  1/511 (0.20%)  3/510 (0.59%)  0/508 (0.00%) 
Fistula, Gi - Rectum * 1  3/511 (0.59%)  0/510 (0.00%)  0/508 (0.00%) 
Obstruction, Gi - Colon * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Gastritis * 1  9/511 (1.76%)  7/510 (1.37%)  10/508 (1.97%) 
Ulcer,gi - Stoma * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Esophagitis * 1  7/511 (1.37%)  5/510 (0.98%)  9/508 (1.77%) 
Hemorrhoids * 1  45/511 (8.81%)  38/510 (7.45%)  24/508 (4.72%) 
Heartburn * 1  97/511 (18.98%)  80/510 (15.69%)  107/508 (21.06%) 
Ulcer,gi - Stomach * 1  2/511 (0.39%)  3/510 (0.59%)  1/508 (0.20%) 
Dental: Teeth * 1  11/511 (2.15%)  10/510 (1.96%)  12/508 (2.36%) 
Mucositis (Functional/Sympt) - Pharynx * 1  4/511 (0.78%)  1/510 (0.20%)  0/508 (0.00%) 
Fistula, Gi - Jejunum * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Ascites * 1  0/511 (0.00%)  10/510 (1.96%)  5/508 (0.98%) 
Fistula, Gi - Anus * 1  0/511 (0.00%)  2/510 (0.39%)  3/508 (0.59%) 
Leak, Gi - Rectum * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Ileus * 1  2/511 (0.39%)  5/510 (0.98%)  3/508 (0.59%) 
Dental: Teeth Development * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Dysphagia * 1  23/511 (4.50%)  23/510 (4.51%)  21/508 (4.13%) 
Distention * 1  47/511 (9.20%)  63/510 (12.35%)  93/508 (18.31%) 
Taste Alteration * 1  117/511 (22.90%)  100/510 (19.61%)  97/508 (19.09%) 
Incontinence, Anal * 1  1/511 (0.20%)  5/510 (0.98%)  5/508 (0.98%) 
Fistula, Gi - Abdomen Nos * 1  0/511 (0.00%)  4/510 (0.78%)  1/508 (0.20%) 
Dry Mouth * 1  22/511 (4.31%)  17/510 (3.33%)  15/508 (2.95%) 
Mucositis (Functional/Sympt) - Stomach * 1  1/511 (0.20%)  1/510 (0.20%)  1/508 (0.20%) 
Obstruction, Gi - Gallbladder * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Mucositis (Functional/Sympt) - Rectum * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Mucositis (Functional/Sympt) - Oral Cavity * 1  89/511 (17.42%)  80/510 (15.69%)  48/508 (9.45%) 
Stricture, Gi - Colon * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Obstruction, Gi - Small Bowel Nos * 1  3/511 (0.59%)  5/510 (0.98%)  6/508 (1.18%) 
Fistula, Gi - Oral Cavity * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
Colitis * 1  4/511 (0.78%)  4/510 (0.78%)  5/508 (0.98%) 
Mucositis (Clinical Exam) - Stomach * 1  1/511 (0.20%)  0/510 (0.00%)  2/508 (0.39%) 
Mucositis (Functional/Sympt) - Anus * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Perforation, Gi - Small Bowel Nos * 1  2/511 (0.39%)  1/510 (0.20%)  0/508 (0.00%) 
Mucositis (Clinical Exam) - Oral Cavity * 1  117/511 (22.90%)  107/510 (20.98%)  76/508 (14.96%) 
Mucositis (Clinical Exam) - Larynx * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Mucositis (Clinical Exam) - Esophagus * 1  1/511 (0.20%)  2/510 (0.39%)  1/508 (0.20%) 
Vomiting * 1  158/511 (30.92%)  160/510 (31.37%)  215/508 (42.32%) 
Anorexia * 1  161/511 (31.51%)  159/510 (31.18%)  211/508 (41.54%) 
Dehydration * 1  26/511 (5.09%)  52/510 (10.20%)  93/508 (18.31%) 
Constipation * 1  321/511 (62.82%)  323/510 (63.33%)  335/508 (65.94%) 
Stricture, Gi - Small Bowel Nos * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Nausea * 1  317/511 (62.04%)  331/510 (64.90%)  393/508 (77.36%) 
Malabsorption * 1  0/511 (0.00%)  2/510 (0.39%)  0/508 (0.00%) 
Gastrointestinal - Other * 1  11/511 (2.15%)  9/510 (1.76%)  10/508 (1.97%) 
Perforation, Gi - Ileum * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Leak, Gi - Stomach * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Diarrhea * 1  224/511 (43.84%)  263/510 (51.57%)  264/508 (51.97%) 
Prolapse Of Stoma, Gi * 1  2/511 (0.39%)  2/510 (0.39%)  0/508 (0.00%) 
Mucositis (Clinical Exam) - Pharynx * 1  3/511 (0.59%)  0/510 (0.00%)  2/508 (0.39%) 
Perforation, Gi - Jejunum * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
General disorders       
Constitutional Symptoms - Other * 1  6/511 (1.17%)  2/510 (0.39%)  2/508 (0.39%) 
Sweating * 1  25/511 (4.89%)  19/510 (3.73%)  23/508 (4.53%) 
Weight Gain * 1  121/511 (23.68%)  105/510 (20.59%)  82/508 (16.14%) 
Patient Odor * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Fever * 1  55/511 (10.76%)  68/510 (13.33%)  62/508 (12.20%) 
Weight Loss * 1  64/511 (12.52%)  80/510 (15.69%)  97/508 (19.09%) 
Hypothermia * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Rigors/Chills * 1  24/511 (4.70%)  26/510 (5.10%)  37/508 (7.28%) 
Fatigue * 1  465/511 (91.00%)  457/510 (89.61%)  451/508 (88.78%) 
Insomnia * 1  160/511 (31.31%)  151/510 (29.61%)  150/508 (29.53%) 
Death No Ctcae Term - Death Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Pain - Other * 1  18/511 (3.52%)  41/510 (8.04%)  31/508 (6.10%) 
Pain: Urethra * 1  14/511 (2.74%)  29/510 (5.69%)  14/508 (2.76%) 
Pain: Perineum * 1  2/511 (0.39%)  4/510 (0.78%)  1/508 (0.20%) 
Pain: Pelvis * 1  21/511 (4.11%)  37/510 (7.25%)  23/508 (4.53%) 
Pain: Breast * 1  2/511 (0.39%)  4/510 (0.78%)  5/508 (0.98%) 
Pain: Vagina * 1  12/511 (2.35%)  9/510 (1.76%)  12/508 (2.36%) 
Pain: Chest /Thorax Nos * 1  44/511 (8.61%)  36/510 (7.06%)  33/508 (6.50%) 
Pain: Chest Wall * 1  18/511 (3.52%)  22/510 (4.31%)  21/508 (4.13%) 
Pain: Throat/Pharynx/Larynx * 1  54/511 (10.57%)  41/510 (8.04%)  36/508 (7.09%) 
Pain: Pleura * 1  2/511 (0.39%)  1/510 (0.20%)  1/508 (0.20%) 
Pain: Larynx * 1  2/511 (0.39%)  2/510 (0.39%)  0/508 (0.00%) 
Pain: Eye * 1  6/511 (1.17%)  5/510 (0.98%)  4/508 (0.79%) 
Pain: Head/Headache * 1  234/511 (45.79%)  201/510 (39.41%)  209/508 (41.14%) 
Pain: Neck * 1  40/511 (7.83%)  38/510 (7.45%)  25/508 (4.92%) 
Pain: Intestine * 1  3/511 (0.59%)  3/510 (0.59%)  3/508 (0.59%) 
Pain: Extremity-Limb * 1  143/511 (27.98%)  133/510 (26.08%)  122/508 (24.02%) 
Pain: Buttock * 1  5/511 (0.98%)  6/510 (1.18%)  0/508 (0.00%) 
Pain: Back * 1  120/511 (23.48%)  115/510 (22.55%)  102/508 (20.08%) 
Pain: Joint * 1  235/511 (45.99%)  210/510 (41.18%)  199/508 (39.17%) 
Pain: Bone * 1  48/511 (9.39%)  44/510 (8.63%)  41/508 (8.07%) 
Pain: Lymph Node * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Pain: Gallbladder * 1  0/511 (0.00%)  2/510 (0.39%)  0/508 (0.00%) 
Pain: Kidney * 1  2/511 (0.39%)  3/510 (0.59%)  5/508 (0.98%) 
Pain: Bladder * 1  10/511 (1.96%)  20/510 (3.92%)  6/508 (1.18%) 
Pain: Pain Nos * 1  23/511 (4.50%)  21/510 (4.12%)  22/508 (4.33%) 
Pain: Stomach * 1  14/511 (2.74%)  8/510 (1.57%)  11/508 (2.17%) 
Pain: Rectum * 1  15/511 (2.94%)  12/510 (2.35%)  6/508 (1.18%) 
Pain: Peritoneum * 1  1/511 (0.20%)  3/510 (0.59%)  1/508 (0.20%) 
Pain: Oral Cavity * 1  28/511 (5.48%)  23/510 (4.51%)  14/508 (2.76%) 
Pain: Esophagus * 1  2/511 (0.39%)  3/510 (0.59%)  2/508 (0.39%) 
Pain: Dental/Teeth/Peridontal * 1  16/511 (3.13%)  10/510 (1.96%)  13/508 (2.56%) 
Pain: Abdominal Pain Nos * 1  243/511 (47.55%)  311/510 (60.98%)  346/508 (68.11%) 
Pain: Scalp * 1  5/511 (0.98%)  3/510 (0.59%)  6/508 (1.18%) 
Pain: Oral - Gums * 1  11/511 (2.15%)  8/510 (1.57%)  6/508 (1.18%) 
Pain: Skin * 1  6/511 (1.17%)  7/510 (1.37%)  4/508 (0.79%) 
Pain: Lip * 1  3/511 (0.59%)  0/510 (0.00%)  0/508 (0.00%) 
Pain: Middle Ear * 1  16/511 (3.13%)  10/510 (1.96%)  5/508 (0.98%) 
Pain: External Ear * 1  8/511 (1.57%)  3/510 (0.59%)  4/508 (0.79%) 
Pain: Cardiac/ Heart * 1  7/511 (1.37%)  5/510 (0.98%)  2/508 (0.39%) 
Pain: Face * 1  4/511 (0.78%)  4/510 (0.78%)  1/508 (0.20%) 
Pain: Muscle * 1  141/511 (27.59%)  127/510 (24.90%)  127/508 (25.00%) 
Pain: Anus * 1  4/511 (0.78%)  6/510 (1.18%)  1/508 (0.20%) 
Pain: Neuralgia * 1  11/511 (2.15%)  10/510 (1.96%)  6/508 (1.18%) 
Pain: Sinus * 1  9/511 (1.76%)  10/510 (1.96%)  4/508 (0.79%) 
Syndromes - Other * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Cytokine Release Syndrome * 1  2/511 (0.39%)  0/510 (0.00%)  3/508 (0.59%) 
Flu-Like Syndrome * 1  12/511 (2.35%)  9/510 (1.76%)  12/508 (2.36%) 
Hepatobiliary disorders       
Cholecystitis * 1  1/511 (0.20%)  1/510 (0.20%)  3/508 (0.59%) 
Liver Dysfunction * 1  3/511 (0.59%)  0/510 (0.00%)  0/508 (0.00%) 
Pancreatitis * 1  1/511 (0.20%)  2/510 (0.39%)  1/508 (0.20%) 
Immune system disorders       
Allergy/Immunology - Other * 1  3/511 (0.59%)  1/510 (0.20%)  1/508 (0.20%) 
Allergic Reaction/Hypersensitivity * 1  36/511 (7.05%)  51/510 (10.00%)  54/508 (10.63%) 
Vasculitis * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Rhinitis * 1  141/511 (27.59%)  119/510 (23.33%)  103/508 (20.28%) 
Autoimmune Reaction * 1  1/511 (0.20%)  2/510 (0.39%)  0/508 (0.00%) 
Infections and infestations       
Inf W/Gr 3 Or 4 Anc: Wound * 1  2/511 (0.39%)  2/510 (0.39%)  3/508 (0.59%) 
Inf W/Gr 3 Or 4 Anc: Blood * 1  2/511 (0.39%)  3/510 (0.59%)  2/508 (0.39%) 
Inf W/Gr 3 Or 4 Anc: Foreign Body * 1  0/511 (0.00%)  2/510 (0.39%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Dental-Tooth * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Colon * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Anal/Perianal * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Ungual (Nails) * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) * 1  4/511 (0.78%)  3/510 (0.59%)  2/508 (0.39%) 
Inf W/Gr 3 Or 4 Anc: Middle Ear * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: External Ear * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva * 1  0/511 (0.00%)  2/510 (0.39%)  2/508 (0.39%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  24/511 (4.70%)  32/510 (6.27%)  28/508 (5.51%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Paranasal * 1  2/511 (0.39%)  2/510 (0.39%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Nose * 1  2/511 (0.39%)  0/510 (0.00%)  3/508 (0.59%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Neck Nos * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Infection (Inf) With Normal Or Grade 1 Or 2 Absolute Neutrophil Count (Anc): Mediastinum Nos * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) * 1  7/511 (1.37%)  8/510 (1.57%)  4/508 (0.79%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Larynx * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos * 1  1/511 (0.20%)  1/510 (0.20%)  4/508 (0.79%) 
Inf W/Gr 3 Or 4 Anc: Peritoneal Cavity * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Small Bowel Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Esophagus * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos * 1  0/511 (0.00%)  2/510 (0.39%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Joint * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Biliary Tree * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urethra * 1  1/511 (0.20%)  0/510 (0.00%)  2/508 (0.39%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  2/511 (0.39%)  3/510 (0.59%)  3/508 (0.59%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  9/511 (1.76%)  16/510 (3.14%)  17/508 (3.35%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Small Bowel Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums * 1  4/511 (0.78%)  6/510 (1.18%)  4/508 (0.79%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos * 1  2/511 (0.39%)  1/510 (0.20%)  2/508 (0.39%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) * 1  13/511 (2.54%)  22/510 (4.31%)  17/508 (3.35%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related * 1  9/511 (1.76%)  10/510 (1.96%)  13/508 (2.56%) 
Febrile Neutropenia * 1  7/511 (1.37%)  10/510 (1.96%)  11/508 (2.17%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral * 1  1/511 (0.20%)  1/510 (0.20%)  2/508 (0.39%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Rectum * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Infection (Inf) Unknown Absolute Neutrophil Count (Anc): Lung (Pneumonia) * 1  0/511 (0.00%)  1/510 (0.20%)  3/508 (0.59%) 
Inf Unknown Anc: Nose * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf Unknown Anc: Sinus * 1  16/511 (3.13%)  7/510 (1.37%)  11/508 (2.17%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth * 1  8/511 (1.57%)  3/510 (0.59%)  5/508 (0.98%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Colon * 1  1/511 (0.20%)  1/510 (0.20%)  1/508 (0.20%) 
Viral Hepatitis * 1  1/511 (0.20%)  2/510 (0.39%)  2/508 (0.39%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  40/511 (7.83%)  42/510 (8.24%)  46/508 (9.06%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos * 1  5/511 (0.98%)  6/510 (1.18%)  6/508 (1.18%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails) * 1  12/511 (2.35%)  13/510 (2.55%)  2/508 (0.39%) 
Inf Unknown Anc: Blood * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf Unknown Anc: Stomach * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Stomach * 1  1/511 (0.20%)  3/510 (0.59%)  1/508 (0.20%) 
Infection - Other * 1  16/511 (3.13%)  12/510 (2.35%)  12/508 (2.36%) 
Inf W/Gr 3 Or 4 Anc: Bladder (Urinary) * 1  5/511 (0.98%)  4/510 (0.78%)  1/508 (0.20%) 
Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia * 1  2/511 (0.39%)  2/510 (0.39%)  1/508 (0.20%) 
Colitis, Infectious (Eg.C. Difficile) * 1  4/511 (0.78%)  9/510 (1.76%)  4/508 (0.79%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums * 1  0/511 (0.00%)  3/510 (0.59%)  1/508 (0.20%) 
Inf Unknown Anc: Vulva * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Inf Unknown Anc: Vagina * 1  1/511 (0.20%)  3/510 (0.59%)  6/508 (1.18%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus * 1  6/511 (1.17%)  8/510 (1.57%)  4/508 (0.79%) 
Inf W/Gr 3 Or 4 Anc: Abdomen Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Mucosa * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf Unknown Anc: Pelvis Nos * 1  1/511 (0.20%)  2/510 (0.39%)  0/508 (0.00%) 
Inf Unknown Anc: Upper Airway Nos * 1  12/511 (2.35%)  12/510 (2.35%)  9/508 (1.77%) 
Inf Unknown Anc: Upper Aerodigestive * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx * 1  5/511 (0.98%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina * 1  8/511 (1.57%)  7/510 (1.37%)  9/508 (1.77%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus * 1  25/511 (4.89%)  27/510 (5.29%)  18/508 (3.54%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos * 1  1/511 (0.20%)  4/510 (0.78%)  2/508 (0.39%) 
Inf Unknown Anc: Pharynx * 1  0/511 (0.00%)  1/510 (0.20%)  2/508 (0.39%) 
Inf Unknown Anc: Mucosa * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Inf Unknown Anc: Bronchus * 1  4/511 (0.78%)  2/510 (0.39%)  3/508 (0.59%) 
Inf Unknown Anc: Eye Nos * 1  2/511 (0.39%)  0/510 (0.00%)  1/508 (0.20%) 
Inf Unknown Anc: Nerve-Cranial * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf Unknown Anc: Soft Tissue Nos * 1  0/511 (0.00%)  0/510 (0.00%)  2/508 (0.39%) 
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity * 1  1/511 (0.20%)  1/510 (0.20%)  4/508 (0.79%) 
Inf Unknown Anc: Urinary Tract Nos * 1  16/511 (3.13%)  26/510 (5.10%)  11/508 (2.17%) 
Inf Unknown Anc: Urethra * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf Unknown Anc: Bladder (Urinary) * 1  6/511 (1.17%)  14/510 (2.75%)  5/508 (0.98%) 
Inf Unknown Anc: Wound * 1  0/511 (0.00%)  2/510 (0.39%)  1/508 (0.20%) 
Inf Unknown Anc: Foreign Body * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Inf Unknown Anc: Catheter-Related * 1  1/511 (0.20%)  4/510 (0.78%)  5/508 (0.98%) 
Inf Unknown Anc: Rectum * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf Unknown Anc: Peritoneal Cavity * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Inf Unknown Anc: Oral Cavity-Gums * 1  1/511 (0.20%)  2/510 (0.39%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body * 1  1/511 (0.20%)  0/510 (0.00%)  3/508 (0.59%) 
Inf Unknown Anc: Dental-Tooth * 1  5/511 (0.98%)  3/510 (0.59%)  7/508 (1.38%) 
Inf Unknown Anc: Colon * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Inf Unknown Anc: Appendix * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf Unknown Anc: Anal/Perianal * 1  2/511 (0.39%)  1/510 (0.20%)  0/508 (0.00%) 
Inf Unknown Anc: Abdomen Nos * 1  0/511 (0.00%)  1/510 (0.20%)  4/508 (0.79%) 
Inf Unknown Anc: Skin (Cellulitis) * 1  9/511 (1.76%)  9/510 (1.76%)  4/508 (0.79%) 
Inf Unknown Anc: Lip/Perioral * 1  0/511 (0.00%)  0/510 (0.00%)  2/508 (0.39%) 
Inf Unknown Anc: Middle Ear * 1  2/511 (0.39%)  1/510 (0.20%)  0/508 (0.00%) 
Inf Unknown Anc: External Ear * 1  1/511 (0.20%)  0/510 (0.00%)  3/508 (0.59%) 
Inf W/Gr 3 Or 4 Anc: Vagina * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos * 1  0/511 (0.00%)  2/510 (0.39%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Upper Aerodigestive * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal * 1  5/511 (0.98%)  5/510 (0.98%)  3/508 (0.59%) 
Inf W/Gr 3 Or 4 Anc: Sinus * 1  4/511 (0.78%)  2/510 (0.39%)  2/508 (0.39%) 
Inf W/Gr 3 Or 4 Anc: Nose * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Mucosa * 1  0/511 (0.00%)  2/510 (0.39%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Eye Nos * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Conjunctiva * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Inf Unknown Anc: Ungual (Nails) * 1  3/511 (0.59%)  5/510 (0.98%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Soft Tissue Nos * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Lymphatic * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  11/511 (2.15%)  7/510 (1.37%)  4/508 (0.79%) 
Inf Unknown Anc: Esophagus * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos * 1  4/511 (0.78%)  11/510 (2.16%)  7/508 (1.38%) 
Inf W/Nml Or Gr 1 Or 2 Anc: External Ear * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Urethra * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Inf W/Gr 3 Or 4 Anc: Catheter-Related * 1  0/511 (0.00%)  3/510 (0.59%)  0/508 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Kidney * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Metabolism and nutrition disorders       
Ast * 1  104/511 (20.35%)  95/510 (18.63%)  85/508 (16.73%) 
Gfr * 1  7/511 (1.37%)  4/510 (0.78%)  20/508 (3.94%) 
Metabolic/Laboratory - Other * 1  19/511 (3.72%)  15/510 (2.94%)  33/508 (6.50%) 
Alkalosis * 1  0/511 (0.00%)  1/510 (0.20%)  2/508 (0.39%) 
Cholesterol,serum High * 1  28/511 (5.48%)  16/510 (3.14%)  6/508 (1.18%) 
Proteinuria * 1  62/511 (12.13%)  65/510 (12.75%)  60/508 (11.81%) 
Hemoglobinuria * 1  1/511 (0.20%)  2/510 (0.39%)  3/508 (0.59%) 
Creatinine * 1  43/511 (8.41%)  33/510 (6.47%)  132/508 (25.98%) 
Hypoalbuminemia * 1  66/511 (12.92%)  74/510 (14.51%)  96/508 (18.90%) 
Gamma-Glutamyl Transferase (Ggt) * 1  5/511 (0.98%)  6/510 (1.18%)  8/508 (1.57%) 
Alanine Aminotransferases (Alt) * 1  98/511 (19.18%)  109/510 (21.37%)  77/508 (15.16%) 
Alkaline Phosphatase * 1  61/511 (11.94%)  86/510 (16.86%)  73/508 (14.37%) 
Bilirubin * 1  18/511 (3.52%)  20/510 (3.92%)  13/508 (2.56%) 
Lipase * 1  0/511 (0.00%)  1/510 (0.20%)  4/508 (0.79%) 
Hypermagnesemia * 1  14/511 (2.74%)  9/510 (1.76%)  22/508 (4.33%) 
Hypophosphatemia * 1  44/511 (8.61%)  32/510 (6.27%)  38/508 (7.48%) 
Hyponatremia * 1  97/511 (18.98%)  113/510 (22.16%)  141/508 (27.76%) 
Hyperuricemia * 1  4/511 (0.78%)  2/510 (0.39%)  3/508 (0.59%) 
Hypertriglyceridemia * 1  14/511 (2.74%)  14/510 (2.75%)  4/508 (0.79%) 
Creatine Phosphokinase (Cpk) * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Bicarbonate, Serum-Low * 1  10/511 (1.96%)  7/510 (1.37%)  12/508 (2.36%) 
Amylase * 1  1/511 (0.20%)  1/510 (0.20%)  5/508 (0.98%) 
Acidosis * 1  3/511 (0.59%)  0/510 (0.00%)  1/508 (0.20%) 
Hypernatremia * 1  15/511 (2.94%)  13/510 (2.55%)  9/508 (1.77%) 
Hypocalcemia * 1  64/511 (12.52%)  72/510 (14.12%)  96/508 (18.90%) 
Hyperkalemia * 1  28/511 (5.48%)  28/510 (5.49%)  49/508 (9.65%) 
Hyperglycemia * 1  148/511 (28.96%)  143/510 (28.04%)  152/508 (29.92%) 
Hypokalemia * 1  74/511 (14.48%)  91/510 (17.84%)  125/508 (24.61%) 
Hypoglycemia * 1  30/511 (5.87%)  28/510 (5.49%)  31/508 (6.10%) 
Hypercalcemia * 1  31/511 (6.07%)  37/510 (7.25%)  45/508 (8.86%) 
Hypomagnesemia * 1  130/511 (25.44%)  190/510 (37.25%)  242/508 (47.64%) 
Musculoskeletal and connective tissue disorders       
Myositis * 1  1/511 (0.20%)  6/510 (1.18%)  1/508 (0.20%) 
Fibrosis-Deep Connective Tissue * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Seroma * 1  2/511 (0.39%)  1/510 (0.20%)  1/508 (0.20%) 
Trismus * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Musculoskeletal/St: Other * 1  6/511 (1.17%)  15/510 (2.94%)  12/508 (2.36%) 
Osteoporosis * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Device/Prosthesis * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Joint-Function * 1  19/511 (3.72%)  23/510 (4.51%)  15/508 (2.95%) 
Joint Effusion * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Fracture * 1  10/511 (1.96%)  7/510 (1.37%)  7/508 (1.38%) 
Fibrosis-Cosmesis * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Extremity-Upper (Function) * 1  1/511 (0.20%)  1/510 (0.20%)  2/508 (0.39%) 
Gait/Walking * 1  8/511 (1.57%)  9/510 (1.76%)  4/508 (0.79%) 
Cervical Spine Rom * 1  4/511 (0.78%)  1/510 (0.20%)  3/508 (0.59%) 
Osteonecrosis * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Arthritis * 1  24/511 (4.70%)  23/510 (4.51%)  31/508 (6.10%) 
Muscle Weakness - Whole Body/Generalized * 1  46/511 (9.00%)  52/510 (10.20%)  71/508 (13.98%) 
Muscle Weakness - Trunk * 1  0/511 (0.00%)  2/510 (0.39%)  2/508 (0.39%) 
Muscle Weakness - Right-Sided * 1  0/511 (0.00%)  1/510 (0.20%)  2/508 (0.39%) 
Muscle Weakness - Left-Sided * 1  2/511 (0.39%)  2/510 (0.39%)  1/508 (0.20%) 
Muscle Weakness - Extremity-Upper * 1  6/511 (1.17%)  12/510 (2.35%)  11/508 (2.17%) 
Muscle Weakness - Extremity-Lower * 1  20/511 (3.91%)  30/510 (5.88%)  17/508 (3.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
2nd Mal: Poss. Related To Cancer Rx * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Nervous system disorders       
Syncope * 1  5/511 (0.98%)  12/510 (2.35%)  24/508 (4.72%) 
Involuntary Movement * 1  15/511 (2.94%)  25/510 (4.90%)  10/508 (1.97%) 
Psychosis * 1  4/511 (0.78%)  0/510 (0.00%)  1/508 (0.20%) 
Myelitis * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Neurology - Other * 1  5/511 (0.98%)  1/510 (0.20%)  5/508 (0.98%) 
Mental Status * 1  0/511 (0.00%)  2/510 (0.39%)  4/508 (0.79%) 
Laryngeal Nerve Dysfunction * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Encephalopathy * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Cns Necrosis * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Mood Alteration - Euphoria * 1  0/511 (0.00%)  2/510 (0.39%)  0/508 (0.00%) 
Mood Alteration - Depression * 1  115/511 (22.50%)  91/510 (17.84%)  98/508 (19.29%) 
Mood Alteration - Anxiety * 1  111/511 (21.72%)  102/510 (20.00%)  122/508 (24.02%) 
Mood Alteration - Agitation * 1  8/511 (1.57%)  11/510 (2.16%)  6/508 (1.18%) 
Tremor * 1  12/511 (2.35%)  13/510 (2.55%)  21/508 (4.13%) 
Speech Impairment * 1  6/511 (1.17%)  5/510 (0.98%)  4/508 (0.79%) 
Seizure * 1  4/511 (0.78%)  5/510 (0.98%)  6/508 (1.18%) 
Personality * 1  2/511 (0.39%)  1/510 (0.20%)  0/508 (0.00%) 
Leukoencephalopathy * 1  0/511 (0.00%)  0/510 (0.00%)  2/508 (0.39%) 
Irritability * 1  2/511 (0.39%)  1/510 (0.20%)  2/508 (0.39%) 
Somnolence * 1  1/511 (0.20%)  0/510 (0.00%)  6/508 (1.18%) 
Cognitive Disturbance * 1  14/511 (2.74%)  11/510 (2.16%)  11/508 (2.17%) 
Cns Ischemia * 1  2/511 (0.39%)  2/510 (0.39%)  7/508 (1.38%) 
Ataxia * 1  5/511 (0.98%)  8/510 (1.57%)  4/508 (0.79%) 
Confusion * 1  18/511 (3.52%)  10/510 (1.96%)  15/508 (2.95%) 
Memory Impairment * 1  38/511 (7.44%)  35/510 (6.86%)  35/508 (6.89%) 
Dizziness * 1  113/511 (22.11%)  107/510 (20.98%)  111/508 (21.85%) 
Neuropathy,cranial - Cn Viii Hearing/Balance * 1  1/511 (0.20%)  2/510 (0.39%)  1/508 (0.20%) 
Neuropathy,cranial - Cn Vii Motor-Face * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Neuropathy,cranial - Cn V Motor-Jaw Muscles * 1  1/511 (0.20%)  2/510 (0.39%)  0/508 (0.00%) 
Neuropathy,cranial - Cn Ii Vision * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Neuropathy,cranial - Cn I Smell * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Neuropathy-Sensory * 1  406/511 (79.45%)  394/510 (77.25%)  407/508 (80.12%) 
Neuropathy-Motor * 1  48/511 (9.39%)  56/510 (10.98%)  35/508 (6.89%) 
Renal and urinary disorders       
Renal/Genitourinary - Other * 1  3/511 (0.59%)  2/510 (0.39%)  9/508 (1.77%) 
Stricture, Anastomotic, Gu - Ureter * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Prolapse Of Stoma, Gu * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Perforation, Gu - Vagina * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Leak, Gu - Vagina * 1  2/511 (0.39%)  1/510 (0.20%)  2/508 (0.39%) 
Leak, Gu - Bladder * 1  2/511 (0.39%)  2/510 (0.39%)  1/508 (0.20%) 
Cystitis * 1  10/511 (1.96%)  15/510 (2.94%)  7/508 (1.38%) 
Urinary Color Change * 1  3/511 (0.59%)  3/510 (0.59%)  0/508 (0.00%) 
Urinary Retention * 1  6/511 (1.17%)  8/510 (1.57%)  10/508 (1.97%) 
Urinary Electrolyte Wasting * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Obstruction, Gu - Ureter * 1  0/511 (0.00%)  5/510 (0.98%)  3/508 (0.59%) 
Obstruction, Gu - Bladder * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Incontinence, Urinary * 1  38/511 (7.44%)  19/510 (3.73%)  27/508 (5.31%) 
Fistula, Gu - Vagina * 1  1/511 (0.20%)  2/510 (0.39%)  0/508 (0.00%) 
Fistula, Gu - Genital Tract-Female * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Fistula, Gu - Bladder * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Bladder Spasm * 1  3/511 (0.59%)  7/510 (1.37%)  1/508 (0.20%) 
Renal Failure * 1  4/511 (0.78%)  1/510 (0.20%)  6/508 (1.18%) 
Urinary Frequency * 1  57/511 (11.15%)  63/510 (12.35%)  63/508 (12.40%) 
Reproductive system and breast disorders       
Libido * 1  12/511 (2.35%)  5/510 (0.98%)  4/508 (0.79%) 
Irregular Menses * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Vaginal Dryness * 1  24/511 (4.70%)  10/510 (1.96%)  19/508 (3.74%) 
Sexual/Reproductive Function: Other * 1  3/511 (0.59%)  2/510 (0.39%)  4/508 (0.79%) 
Vaginitis * 1  7/511 (1.37%)  7/510 (1.37%)  5/508 (0.98%) 
Vaginal Mucositis * 1  5/511 (0.98%)  3/510 (0.59%)  2/508 (0.39%) 
Vaginal Discharge * 1  21/511 (4.11%)  19/510 (3.73%)  22/508 (4.33%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary: Other * 1  10/511 (1.96%)  7/510 (1.37%)  6/508 (1.18%) 
Airway Obstruction - Trachea * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Airway Obstruction - Bronchus * 1  1/511 (0.20%)  2/510 (0.39%)  0/508 (0.00%) 
Nasal/Paranasal Reactions * 1  101/511 (19.77%)  81/510 (15.88%)  67/508 (13.19%) 
Edema, Larynx * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Bronchospasm * 1  11/511 (2.15%)  7/510 (1.37%)  5/508 (0.98%) 
Atelectasis * 1  3/511 (0.59%)  2/510 (0.39%)  2/508 (0.39%) 
Aspiration * 1  4/511 (0.78%)  0/510 (0.00%)  1/508 (0.20%) 
Voice Changes * 1  75/511 (14.68%)  57/510 (11.18%)  58/508 (11.42%) 
Pneumothorax * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Hypoxia * 1  10/511 (1.96%)  2/510 (0.39%)  3/508 (0.59%) 
Hiccoughs * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Cough * 1  143/511 (27.98%)  147/510 (28.82%)  116/508 (22.83%) 
Ards * 1  1/511 (0.20%)  1/510 (0.20%)  1/508 (0.20%) 
Pneumonitis * 1  2/511 (0.39%)  2/510 (0.39%)  1/508 (0.20%) 
Pleural Effusion * 1  9/511 (1.76%)  7/510 (1.37%)  0/508 (0.00%) 
Dyspnea * 1  202/511 (39.53%)  203/510 (39.80%)  143/508 (28.15%) 
Skin and subcutaneous tissue disorders       
Nail Changes * 1  137/511 (26.81%)  113/510 (22.16%)  48/508 (9.45%) 
Photosensitivity * 1  1/511 (0.20%)  2/510 (0.39%)  2/508 (0.39%) 
Injection Site Reaction * 1  7/511 (1.37%)  11/510 (2.16%)  19/508 (3.74%) 
Hair Loss/Alopecia (Scalp Or Body) * 1  402/511 (78.67%)  378/510 (74.12%)  377/508 (74.21%) 
Erythema Multiforme * 1  3/511 (0.59%)  2/510 (0.39%)  1/508 (0.20%) 
Dermatitis - Chemoradiation * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Hypopigmentation * 1  4/511 (0.78%)  4/510 (0.78%)  3/508 (0.59%) 
Induration * 1  2/511 (0.39%)  9/510 (1.76%)  3/508 (0.59%) 
Cheilitis * 1  3/511 (0.59%)  1/510 (0.20%)  2/508 (0.39%) 
Wound Complication, Non-Infectious * 1  34/511 (6.65%)  43/510 (8.43%)  46/508 (9.06%) 
Bruising * 1  43/511 (8.41%)  49/510 (9.61%)  31/508 (6.10%) 
Acne * 1  5/511 (0.98%)  13/510 (2.55%)  16/508 (3.15%) 
Rash * 1  186/511 (36.40%)  192/510 (37.65%)  121/508 (23.82%) 
Dry Skin * 1  61/511 (11.94%)  51/510 (10.00%)  29/508 (5.71%) 
Decubitus * 1  0/511 (0.00%)  2/510 (0.39%)  4/508 (0.79%) 
Atrophy, Skin * 1  1/511 (0.20%)  0/510 (0.00%)  2/508 (0.39%) 
Telangiectasia * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Pruritus * 1  43/511 (8.41%)  39/510 (7.65%)  36/508 (7.09%) 
Burn * 1  4/511 (0.78%)  6/510 (1.18%)  0/508 (0.00%) 
Urticaria * 1  5/511 (0.98%)  4/510 (0.78%)  2/508 (0.39%) 
Flushing * 1  30/511 (5.87%)  26/510 (5.10%)  25/508 (4.92%) 
Hand-Foot * 1  13/511 (2.54%)  11/510 (2.16%)  6/508 (1.18%) 
Dermatology/Skin - Other * 1  17/511 (3.33%)  24/510 (4.71%)  9/508 (1.77%) 
Hyperpigmentation * 1  15/511 (2.94%)  20/510 (3.92%)  8/508 (1.57%) 
Ulceration * 1  8/511 (1.57%)  13/510 (2.55%)  4/508 (0.79%) 
Surgical and medical procedures       
Intra-Operative (Op) Injury: Nerves: Peripheral Motor Nos * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Intra-Op Injury: Teeth * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Intra-Op Injury: Nasal Cavity * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Intra-Op Injury: Kidney * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Intra-Op Injury: Small Bowel Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Intra-Op Injury: Peritoneal Cavity * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Intra-Op Injury: Colon * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Intra-Op Injury: Abdomen Nos * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Intra-Op Injury: Adrenal Gland * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Vascular disorders       
Inr * 1  12/511 (2.35%)  10/510 (1.96%)  16/508 (3.15%) 
Partial Throboplastin Time (Ptt) * 1  10/511 (1.96%)  10/510 (1.96%)  12/508 (2.36%) 
Hemorrhage, Gu - Stoma * 1  0/511 (0.00%)  1/510 (0.20%)  1/508 (0.20%) 
Hemorrhage, Gu - Urinary Nos * 1  6/511 (1.17%)  5/510 (0.98%)  4/508 (0.79%) 
Hemorrhage, Gu - Vagina * 1  16/511 (3.13%)  21/510 (4.12%)  9/508 (1.77%) 
Hemorrhage/Pulmonary - Bronchopulmonary Nos * 1  3/511 (0.59%)  1/510 (0.20%)  1/508 (0.20%) 
Hemorrhage/Pulmonary - Lung * 1  0/511 (0.00%)  1/510 (0.20%)  2/508 (0.39%) 
Hemorrhage/Pulmonary - Pharynx * 1  1/511 (0.20%)  1/510 (0.20%)  0/508 (0.00%) 
Hemorrhage, Gi - Rectum * 1  36/511 (7.05%)  23/510 (4.51%)  15/508 (2.95%) 
Hemorrhage/Pulmonary - Respiratory Tract Nos * 1  2/511 (0.39%)  3/510 (0.59%)  1/508 (0.20%) 
Hemorrhage, Gi - Stoma * 1  2/511 (0.39%)  0/510 (0.00%)  0/508 (0.00%) 
Hemorrhage, Gi - Varices (Rectal) * 1  3/511 (0.59%)  1/510 (0.20%)  3/508 (0.59%) 
Hemorrhage, Gi - Peritoneal Cavity * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Hemorrhage, Gi - Upper Gi Nos * 1  1/511 (0.20%)  1/510 (0.20%)  1/508 (0.20%) 
Hemorrhage/Pulmonary - Nose * 1  261/511 (51.08%)  231/510 (45.29%)  184/508 (36.22%) 
Hematoma * 1  2/511 (0.39%)  8/510 (1.57%)  11/508 (2.17%) 
Hemorrhage, Gi - Anus * 1  8/511 (1.57%)  12/510 (2.35%)  5/508 (0.98%) 
Hemorrhage, Gi - Esophagus * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Hemorrhage, Gu - Ureter * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Hemorrhage, Gi - Duodenum * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Hemorrhage, Gi - Lower Gi Nos * 1  4/511 (0.78%)  2/510 (0.39%)  5/508 (0.98%) 
Hemorrhage, Gi - Oral Cavity * 1  38/511 (7.44%)  32/510 (6.27%)  26/508 (5.12%) 
Hemorrhage, Gu - Kidney * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Hemorrhage, Gu - Bladder * 1  3/511 (0.59%)  1/510 (0.20%)  4/508 (0.79%) 
Hemorrhage, Gi - Stomach * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Hemorrhage, Gi - Colon * 1  2/511 (0.39%)  0/510 (0.00%)  1/508 (0.20%) 
Hemorrhage, Cns * 1  0/511 (0.00%)  3/510 (0.59%)  4/508 (0.79%) 
Petechiae * 1  9/511 (1.76%)  2/510 (0.39%)  3/508 (0.59%) 
Hemorrhage/Bleeding - Other * 1  2/511 (0.39%)  2/510 (0.39%)  3/508 (0.59%) 
Vascular - Other * 1  1/511 (0.20%)  0/510 (0.00%)  1/508 (0.20%) 
Visceral Arterial Ischemia * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Vein Injury - Other Nos * 1  0/511 (0.00%)  1/510 (0.20%)  0/508 (0.00%) 
Peripheral Arterial Ischemia * 1  0/511 (0.00%)  0/510 (0.00%)  1/508 (0.20%) 
Vein Injury - Extremity-Lower * 1  1/511 (0.20%)  0/510 (0.00%)  0/508 (0.00%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  7/511 (1.37%)  5/510 (0.98%)  10/508 (1.97%) 
Thrombosis/Thrombus/Embolism * 1  21/511 (4.11%)  27/510 (5.29%)  30/508 (5.91%) 
Phlebitis * 1  1/511 (0.20%)  6/510 (1.18%)  5/508 (0.98%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: Linda Gedeon for Mark Brady, PhD
Organization: NRG Oncology
Phone: 716-845-1169
EMail: lgedeon@gogstats.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00951496     History of Changes
Other Study ID Numbers: NCI-2011-01956
NCI-2011-01956 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
09-0724
CDR0000650601
GOG-0252 ( Other Identifier: NRG Oncology )
GOG-0252 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: August 1, 2009
First Posted: August 4, 2009
Results First Submitted: October 4, 2017
Results First Posted: May 18, 2018
Last Update Posted: November 8, 2019