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Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube 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: NCT00262847
Recruitment Status : Completed
First Posted : December 7, 2005
Results First Posted : September 18, 2013
Last Update Posted : July 23, 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: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Fallopian Tube Clear Cell Adenocarcinoma
Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube Mucinous Adenocarcinoma
Fallopian Tube Serous Adenocarcinoma
Fallopian Tube Transitional Cell Carcinoma
Malignant Ovarian Mixed Epithelial Tumor
Ovarian Brenner Tumor
Ovarian Clear Cell Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Adenocarcinoma
Ovarian Serous Adenocarcinoma
Ovarian Transitional Cell Carcinoma
Primary Peritoneal Serous Adenocarcinoma
Stage IIIA Fallopian Tube Cancer
Stage IIIA Ovarian Cancer
Stage IIIA Primary Peritoneal Cancer
Stage IIIB Fallopian Tube Cancer
Stage IIIB Ovarian Cancer
Stage IIIB Primary Peritoneal Cancer
Stage IIIC Fallopian Tube Cancer
Stage IIIC Ovarian Cancer
Stage IIIC Primary Peritoneal Cancer
Stage IV Fallopian Tube Cancer
Stage IV Ovarian Cancer
Stage IV Primary Peritoneal Cancer
Undifferentiated Fallopian Tube Carcinoma
Undifferentiated Ovarian Carcinoma
Interventions Biological: Bevacizumab
Drug: Carboplatin
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Placebo
Other: Quality-of-Life Assessment
Enrollment 1873
Recruitment Details Between October 2005 and June 2009, 1873 women were enrolled from 336 institutions in the United States, Canada, South Korea, and Japan.
Pre-assignment Details  
Arm/Group Title Arm I (Placebo, Paclitaxel, Carboplatin) Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) Arm III (Paclitaxel, Carboplatin, Bevacizumab)
Hide Arm/Group Description

Control therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-initiation therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-throughout therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.

Period Title: Overall Study
Started 625 [1] 625 [1] 623 [1]
Completed 107 112 227
Not Completed 518 513 396
Reason Not Completed
Disease Progression             309             274             195
Patient Refusal             41             52             47
Adverse Event             74             88             108
Death             8             8             11
Concomitant disease             3             2             4
Other Reasons             79             88             27
Did not receive study treatment             4             1             4
[1]
Total enrolled and included in efficacy analysis
Arm/Group Title Arm I (Placebo, Paclitaxel, Carboplatin) Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) Arm III (Paclitaxel, Carboplatin, Bevacizumab) Total
Hide Arm/Group Description

Control therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-initiation therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-throughout therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 625 625 623 1873
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 625 participants 625 participants 623 participants 1873 participants
59.3  (10.9) 60.1  (10.3) 59.7  (10.6) 59.7  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 625 participants 625 participants 623 participants 1873 participants
Female
625
 100.0%
625
 100.0%
623
 100.0%
1873
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 625 participants 625 participants 623 participants 1873 participants
Non-Hispanic white 526 519 521 1566
Asian 41 37 39 117
Non-Hispanic black 25 28 27 80
Hispanic 21 28 25 74
Other or unspecified 12 13 11 36
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 625 participants 625 participants 623 participants 1873 participants
United States 596 596 599 1791
Canada 1 5 3 9
Japan 21 12 12 45
Korea, Republic of 7 12 9 28
Gynecologic Oncology Group (GOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 625 participants 625 participants 623 participants 1873 participants
0 - fully active 311 315 305 931
1 - restricted strenuous activity, ambulatory 272 270 267 809
2 - ambulatory, difficulty walking 42 40 51 133
3 - limited self-care, partly confined to bed 0 0 0 0
4 - completely disabled, no self-care 0 0 0 0
[1]
Measure Description: 5-point, ordinal scale specifying patient's ability to perform activities from 0(fully active) to 4(completely disabled, no self-care).
International Federation of Gynecologic and Obstetrics (FIGO) Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 625 participants 625 participants 623 participants 1873 participants
1-limited to ovaries 0 0 0 0
1A-1 ovary involved, no ascites 0 0 0 0
1B-both ovaries involved, no ascites 0 0 0 0
1C-disease with capsules ruptured or ascites 0 0 0 0
2-disease with pelvic extension 0 0 0 0
2A-disease with extension to uterus and or tubes 0 0 0 0
2B-disease with extension to other pelvic tissues 0 0 0 0
2C-disease with capsules ruptured or ascites 0 0 0 0
3-disease w/ macroscopic implants outside pelvis 218 205 216 639
3-disease w/ implants > 1 cm outside pelvis 254 256 242 752
3A-disease w/ microscopic implants, negative nodes 0 0 0 0
3B-disease w/ abdominal implants <2cm, neg nodes 0 0 0 0
3C-disease w/ abdominal implants >2cm, pos nodes 0 0 0 0
4-distant metastatis 153 164 165 482
[1]
Measure Description: Clinical staging for primary carcinoma of the ovary (1985) from Stage 1 (limited to ovaries) to Stage 4 (distant metastatis)
Histologic Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 625 participants 625 participants 623 participants 1873 participants
Serous adenocarcinoma 541 519 524 1584
Endometrioid 21 14 24 59
Clear cell 12 23 20 55
Mucinous 6 5 8 19
Other or not specified 45 64 47 156
[1]
Measure Description: Histologic(cell) type was obtained from the central GOG Pathology Committee review updated in September 2010.
Tumor Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 625 participants 625 participants 623 participants 1873 participants
3 445 465 460 1370
2 102 86 97 285
1 36 28 18 82
Not graded 42 46 48 136
[1]
Measure Description: Tumor grade was obtained from the central GOG Pathology Committee review updated in September 2010. All clear-cell tumors were classified as grade 3.
1.Primary Outcome
Title Progression-free Survival
Hide Description Median progression-free survival (PFS). Onset of progression could be based on radiographic (RECIST) criteria or rising CA-125 (GCIG criteria).
Time Frame From study entry until first disease progression, death or date of last contact, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Placebo, Paclitaxel, Carboplatin) Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) Arm III (Paclitaxel, Carboplatin, Bevacizumab)
Hide Arm/Group Description:

Control therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-initiation therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-throughout therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.

Overall Number of Participants Analyzed 625 625 623
Median (95% Confidence Interval)
Unit of Measure: months
11.0
(10.2 to 12.0)
12.3
(11.4 to 12.8)
15.3
(14.2 to 16.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Placebo, Paclitaxel, Carboplatin), Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.448
Comments [Not Specified]
Method Regression, Cox
Comments Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.954
Confidence Interval 95%
0.844 to 1.078
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Placebo, Paclitaxel, Carboplatin), Arm III (Paclitaxel, Carboplatin, Bevacizumab)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Regression, Cox
Comments Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.765
Confidence Interval 95%
0.676 to 0.866
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Overall Survival
Hide Description Median overall survival (OS)
Time Frame From study entry to death or last contact, up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Placebo, Paclitaxel, Carboplatin) Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) Arm III (Paclitaxel, Carboplatin, Bevacizumab)
Hide Arm/Group Description:

Control therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-initiation therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-throughout therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.

Overall Number of Participants Analyzed 625 625 623
Median (95% Confidence Interval)
Unit of Measure: months
40.6
(37.1 to 45.5)
38.7
(35.2 to 42.1)
43.8
(39.7 to 49.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Placebo, Paclitaxel, Carboplatin), Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.410
Comments [Not Specified]
Method Regression, Cox
Comments Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.069
Confidence Interval 95%
0.912 to 1.255
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm I (Placebo, Paclitaxel, Carboplatin), Arm III (Paclitaxel, Carboplatin, Bevacizumab)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method Regression, Cox
Comments Proportional Hazards model stratified by stage of disease and size of residual disease following initial staging surgery.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.880
Confidence Interval 95%
0.746 to 1.039
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Frequency and Severity (Grade 3 or Above) of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 3.0
Hide Description Eligible and Evaluable patients
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable patients
Arm/Group Title Arm I Toxicities (Placebo, Paclitaxel, Carboplatin) Arm II Toxicities (Placabo,Paclitaxel,Carboplatin,Bevacizumab) Arm III Toxicities (Paclitaxel, Carboplatin, Bevacizumab)
Hide Arm/Group Description:

Control therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-initiation therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-throughout therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.

Overall Number of Participants Analyzed 621 624 619
Measure Type: Count of Participants
Unit of Measure: Participants
White blood cell
317
  51.0%
328
  52.6%
327
  52.8%
Absolute neutrophil count
540
  87.0%
543
  87.0%
536
  86.6%
Hemoglobin
91
  14.7%
86
  13.8%
74
  12.0%
Platelets
93
  15.0%
122
  19.6%
131
  21.2%
Other hematologic
13
   2.1%
13
   2.1%
9
   1.5%
Allergy/Immunology
23
   3.7%
25
   4.0%
14
   2.3%
Auditory/Ear
1
   0.2%
1
   0.2%
2
   0.3%
hypertension
10
   1.6%
36
   5.8%
65
  10.5%
Cardiac
14
   2.3%
12
   1.9%
18
   2.9%
Coagulation
5
   0.8%
7
   1.1%
8
   1.3%
Constitutional
62
  10.0%
61
   9.8%
83
  13.4%
Dermatologic
13
   2.1%
20
   3.2%
16
   2.6%
Endocrine
4
   0.6%
4
   0.6%
2
   0.3%
Gastrointestinal
96
  15.5%
112
  17.9%
122
  19.7%
Genitourinary/Renal
13
   2.1%
8
   1.3%
8
   1.3%
Hemorrhage
5
   0.8%
9
   1.4%
15
   2.4%
Hepatobiliary
2
   0.3%
1
   0.2%
3
   0.5%
Infection
75
  12.1%
73
  11.7%
95
  15.3%
Lymphatics
4
   0.6%
3
   0.5%
3
   0.5%
Metabolic
91
  14.7%
87
  13.9%
101
  16.3%
Musculoskeletal
16
   2.6%
17
   2.7%
21
   3.4%
Neurosensory
23
   3.7%
26
   4.2%
28
   4.5%
Other neurological
44
   7.1%
42
   6.7%
65
  10.5%
Ocular/Visual
4
   0.6%
1
   0.2%
4
   0.6%
Pain
74
  11.9%
82
  13.1%
101
  16.3%
Pulmonary
29
   4.7%
36
   5.8%
32
   5.2%
Vascular
37
   6.0%
33
   5.3%
40
   6.5%
Death, not CTC coded
5
   0.8%
8
   1.3%
10
   1.6%
Sexual/Reproductive
1
   0.2%
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Impact on Quality of Life Measured by the Functional Assessment of Cancer Therapy-Ovary Trial Outcome Index (FACT-O TOI)
Hide Description Estimated least squares means from a mixed module of Quality of Life (QOL) scores at each assessment point, adjusted for baseline score and patient's age. Note: The range of possible scores of the FACT-O TOI is 0 - 104 for all treatment groups and at all visits. A higher score indicates better QOL. Baseline mean scores are raw means.
Time Frame At baseline, 9, 18, 36, 60, and 84 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of valid QOL assessments do not total number of patients randomized in study.
Arm/Group Title Arm I (Placebo, Paclitaxel, Carboplatin) Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) Arm III (Paclitaxel, Carboplatin, Bevacizumab)
Hide Arm/Group Description:

Control therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-initiation therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-throughout therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.

Overall Number of Participants Analyzed 625 625 623
Least Squares Mean (Standard Deviation)
Unit of Measure: units on a scale
prior to treatment 68.2  (0.64) 68.0  (0.66) 67.4  (0.65)
prior to cycle 4 73.8  (0.53) 71.1  (0.56) 70.9  (0.54)
prior to cycle 7 76.0  (0.54) 74.3  (0.56) 73.8  (0.58)
prior to cycle 13 80.6  (0.62) 80.5  (0.62) 79.9  (0.58)
prior to cycle 21 77.6  (0.73) 79.1  (0.71) 78.6  (0.66)
6 months followup 75.8  (0.78) 77.6  (0.75) 77.8  (0.75)
Time Frame All Adverse Events(AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. Also reported are Serious Adeverse Events (SAEs) considered to be treatment related for up to 5 years after stopping study treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Placebo, Paclitaxel, Carboplatin) Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) Arm III (Paclitaxel, Carboplatin, Bevacizumab)
Hide Arm/Group Description

Control therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-initiation therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received placebo every 3 weeks.

Bevacizumab-throughout therapy:

Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.

Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks.

All-Cause Mortality
Arm I (Placebo, Paclitaxel, Carboplatin) Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) Arm III (Paclitaxel, Carboplatin, Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Placebo, Paclitaxel, Carboplatin) Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) Arm III (Paclitaxel, Carboplatin, Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   239/621 (38.49%)   257/624 (41.19%)   287/619 (46.37%) 
Blood and lymphatic system disorders       
Myelodysplasia  1  0/621 (0.00%)  1/624 (0.16%)  1/619 (0.16%) 
Neutrophils  1  14/621 (2.25%)  15/624 (2.40%)  13/619 (2.10%) 
Platelets  1  1/621 (0.16%)  2/624 (0.32%)  0/619 (0.00%) 
Leukocytes  1  1/621 (0.16%)  2/624 (0.32%)  3/619 (0.48%) 
Hemoglobin  1  3/621 (0.48%)  2/624 (0.32%)  1/619 (0.16%) 
Lymphocele  1  1/621 (0.16%)  0/624 (0.00%)  1/619 (0.16%) 
Cardiac disorders       
S/N Arrhythmia: Atrial Fibrillation  1  3/621 (0.48%)  0/624 (0.00%)  1/619 (0.16%) 
Cardiac Arrhythmia - Other  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
S/N Arrhythmia: Atrial Flutter  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Vasovagal Episode  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Supraventricular Tachycardia  1  0/621 (0.00%)  0/624 (0.00%)  2/619 (0.32%) 
S/N Arrhythmia:supraventricular Nos  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
S/N Arrhythmia: Sinus Bradycardia  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Cardiac Ischemia/Infarction  1  2/621 (0.32%)  2/624 (0.32%)  1/619 (0.16%) 
Hypertension  1  0/621 (0.00%)  4/624 (0.64%)  5/619 (0.81%) 
Left Venticular Diastolic Dysfunction  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Cardiac General - Other  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Cardiac Troponin I (Ctni)  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Hypotension  1  1/621 (0.16%)  0/624 (0.00%)  2/619 (0.32%) 
Endocrine disorders       
Endocrine - Other  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Eye disorders       
Cataract  1  0/621 (0.00%)  0/624 (0.00%)  2/619 (0.32%) 
Gastrointestinal disorders       
Fistula, Gi - Colon/Cecum/Appendix  1  1/621 (0.16%)  2/624 (0.32%)  1/619 (0.16%) 
Obstruction, Gi - Ileum  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Necrosis, Gi - Small Bowel Nos  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Perforation, Gi - Colon  1  0/621 (0.00%)  4/624 (0.64%)  4/619 (0.65%) 
Fistula, Gi - Ileum  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Fistula, Gi - Small Bowel Nos  1  0/621 (0.00%)  2/624 (0.32%)  1/619 (0.16%) 
Fistula, Gi - Rectum  1  1/621 (0.16%)  1/624 (0.16%)  1/619 (0.16%) 
Obstruction, Gi - Colon  1  2/621 (0.32%)  0/624 (0.00%)  1/619 (0.16%) 
Gastritis  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Hemorrhoids  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Mucositis (Functional/Sympt) - Esophagus  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Leak, Gi - Large Bowel  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Perforation, Gi - Rectum  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Leak, Gi - Rectum  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Ileus  1  5/621 (0.81%)  8/624 (1.28%)  3/619 (0.48%) 
Fistula, Gi - Abdomen Nos  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Obstruction, Gi - Duodenal  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Obstruction, Gi - Small Bowel Nos  1  13/621 (2.09%)  13/624 (2.08%)  15/619 (2.42%) 
Colitis  1  3/621 (0.48%)  1/624 (0.16%)  5/619 (0.81%) 
Obstruction, Gi - Jejunum  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Perforation, Gi - Small Bowel Nos  1  1/621 (0.16%)  1/624 (0.16%)  1/619 (0.16%) 
Vomiting  1  12/621 (1.93%)  9/624 (1.44%)  6/619 (0.97%) 
Anorexia  1  2/621 (0.32%)  0/624 (0.00%)  0/619 (0.00%) 
Dehydration  1  9/621 (1.45%)  10/624 (1.60%)  11/619 (1.78%) 
Constipation  1  4/621 (0.64%)  4/624 (0.64%)  3/619 (0.48%) 
Nausea  1  4/621 (0.64%)  3/624 (0.48%)  5/619 (0.81%) 
Gastrointestinal - Other  1  1/621 (0.16%)  2/624 (0.32%)  1/619 (0.16%) 
Diarrhea  1  5/621 (0.81%)  3/624 (0.48%)  7/619 (1.13%) 
Prolapse Of Stoma, Gi  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
General disorders       
Fever  1  3/621 (0.48%)  2/624 (0.32%)  5/619 (0.81%) 
Fatigue  1  1/621 (0.16%)  4/624 (0.64%)  2/619 (0.32%) 
Death No Ctcae Term - Disease Progression Nos  1  0/621 (0.00%)  4/624 (0.64%)  1/619 (0.16%) 
Death No Ctcae Term - Death Nos  1  0/621 (0.00%)  0/624 (0.00%)  2/619 (0.32%) 
Death No Ctcae Term - Multi-Organ Failure  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Death No Ctcae Term - Sudden Death  1  1/621 (0.16%)  2/624 (0.32%)  2/619 (0.32%) 
Pain - Other  1  0/621 (0.00%)  1/624 (0.16%)  1/619 (0.16%) 
Pain: Pelvis  1  0/621 (0.00%)  1/624 (0.16%)  1/619 (0.16%) 
Pain: Chest /Thorax Nos  1  1/621 (0.16%)  1/624 (0.16%)  4/619 (0.65%) 
Pain: Chest Wall  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Pain: Pleura  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Pain: Head/Headache  1  1/621 (0.16%)  1/624 (0.16%)  0/619 (0.00%) 
Pain: Intestine  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Pain: Back  1  0/621 (0.00%)  1/624 (0.16%)  1/619 (0.16%) 
Pain: Joint  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Pain: Bone  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Pain: Kidney  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Pain: Pain Nos  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Pain: Rectum  1  2/621 (0.32%)  1/624 (0.16%)  0/619 (0.00%) 
Pain: Abdominal Pain Nos  1  8/621 (1.29%)  8/624 (1.28%)  12/619 (1.94%) 
Pain: Muscle  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Hepatobiliary disorders       
Hepatobiliary/Pancreas - Other  1  1/621 (0.16%)  0/624 (0.00%)  1/619 (0.16%) 
Cholecystitis  1  0/621 (0.00%)  2/624 (0.32%)  3/619 (0.48%) 
Pancreatitis  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Immune system disorders       
Allergy/Immunology - Other  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Allergic Reaction/Hypersensitivity  1  3/621 (0.48%)  6/624 (0.96%)  4/619 (0.65%) 
Infections and infestations       
Inf W/Gr 3 Or 4 Anc: Wound  1  1/621 (0.16%)  0/624 (0.00%)  1/619 (0.16%) 
Inf W/Gr 3 Or 4 Anc: Blood  1  3/621 (0.48%)  1/624 (0.16%)  1/619 (0.16%) 
Inf W/Gr 3 Or 4 Anc: Salivary Gland  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)  1  1/621 (0.16%)  0/624 (0.00%)  1/619 (0.16%) 
Inf W/Gr 3 Or 4 Anc: External Ear  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)  1  2/621 (0.32%)  3/624 (0.48%)  3/619 (0.48%) 
Inf W/Gr 3 Or 4 Anc: Peritoneal Cavity  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Esophagus  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bone  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood  1  3/621 (0.48%)  3/624 (0.48%)  1/619 (0.16%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound  1  1/621 (0.16%)  2/624 (0.32%)  1/619 (0.16%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)  1  2/621 (0.32%)  0/624 (0.00%)  2/619 (0.32%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related  1  1/621 (0.16%)  2/624 (0.32%)  2/619 (0.32%) 
Febrile Neutropenia  1  16/621 (2.58%)  20/624 (3.21%)  21/619 (3.39%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Rectum  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Inf Unknown Anc: Lung (Pneumonia)  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos  1  0/621 (0.00%)  1/624 (0.16%)  2/619 (0.32%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos  1  1/621 (0.16%)  3/624 (0.48%)  4/619 (0.65%) 
Infection - Other  1  4/621 (0.64%)  4/624 (0.64%)  3/619 (0.48%) 
Inf W/Gr 3 Or 4 Anc: Bladder (Urinary)  1  0/621 (0.00%)  2/624 (0.32%)  3/619 (0.48%) 
Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Colitis, Infectious (Eg.C. Difficile)  1  1/621 (0.16%)  3/624 (0.48%)  0/619 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Abdomen Nos  1  3/621 (0.48%)  0/624 (0.00%)  0/619 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Inf Unknown Anc: Neck Nos  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity  1  1/621 (0.16%)  0/624 (0.00%)  1/619 (0.16%) 
Inf Unknown Anc: Catheter-Related  1  0/621 (0.00%)  2/624 (0.32%)  0/619 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Pelvis Nos  1  0/621 (0.00%)  2/624 (0.32%)  0/619 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Inf W/Gr 3 Or 4 Anc: Sinus  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia)  1  3/621 (0.48%)  2/624 (0.32%)  1/619 (0.16%) 
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos  1  3/621 (0.48%)  4/624 (0.64%)  3/619 (0.48%) 
Inf W/Gr 3 Or 4 Anc: Catheter-Related  1  2/621 (0.32%)  0/624 (0.00%)  1/619 (0.16%) 
Metabolism and nutrition disorders       
Proteinuria  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Creatinine  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Hypoalbuminemia  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Alt  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Hyponatremia  1  1/621 (0.16%)  1/624 (0.16%)  3/619 (0.48%) 
Hyperglycemia  1  0/621 (0.00%)  2/624 (0.32%)  2/619 (0.32%) 
Hypokalemia  1  3/621 (0.48%)  0/624 (0.00%)  2/619 (0.32%) 
Hypoglycemia  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Hypercalcemia  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Hypomagnesemia  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Musculoskeletal and connective tissue disorders       
Musculoskeletal/St: Other  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Soft Tissue Necrosis - Abdomen  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Joint-Function  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Joint Effusion  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Fracture  1  2/621 (0.32%)  0/624 (0.00%)  3/619 (0.48%) 
Osteonecrosis  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Arthritis  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Muscle Weakness - Whole Body/Generalized  1  0/621 (0.00%)  0/624 (0.00%)  2/619 (0.32%) 
Muscle Weakness - Extremity-Lower  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
2nd Mal: Poss. Related To Cancer Rx  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Nervous system disorders       
Syncope  1  5/621 (0.81%)  4/624 (0.64%)  2/619 (0.32%) 
Psychosis  1  1/621 (0.16%)  1/624 (0.16%)  0/619 (0.00%) 
Neurology - Other  1  1/621 (0.16%)  0/624 (0.00%)  2/619 (0.32%) 
Encephalopathy  1  0/621 (0.00%)  1/624 (0.16%)  1/619 (0.16%) 
Mood Alteration - Depression  1  1/621 (0.16%)  0/624 (0.00%)  1/619 (0.16%) 
Mood Alteration - Anxiety  1  0/621 (0.00%)  1/624 (0.16%)  1/619 (0.16%) 
Seizure  1  1/621 (0.16%)  0/624 (0.00%)  1/619 (0.16%) 
Cognitive Disturbance  1  0/621 (0.00%)  2/624 (0.32%)  0/619 (0.00%) 
Cns Ischemia  1  3/621 (0.48%)  0/624 (0.00%)  5/619 (0.81%) 
Confusion  1  1/621 (0.16%)  1/624 (0.16%)  1/619 (0.16%) 
Dizziness  1  2/621 (0.32%)  1/624 (0.16%)  2/619 (0.32%) 
Neuropathy-Sensory  1  2/621 (0.32%)  0/624 (0.00%)  0/619 (0.00%) 
Neuropathy-Motor  1  0/621 (0.00%)  2/624 (0.32%)  1/619 (0.16%) 
Renal and urinary disorders       
Perforation, Gu - Vagina  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Obstruction, Gu - Ureter  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Fistula, Gu - Vagina  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary: Other  1  3/621 (0.48%)  2/624 (0.32%)  2/619 (0.32%) 
Bronchospasm  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Pneumothorax  1  2/621 (0.32%)  0/624 (0.00%)  1/619 (0.16%) 
Pneumonitis  1  1/621 (0.16%)  1/624 (0.16%)  1/619 (0.16%) 
Pleural Effusion  1  1/621 (0.16%)  3/624 (0.48%)  1/619 (0.16%) 
Dyspnea  1  3/621 (0.48%)  6/624 (0.96%)  7/619 (1.13%) 
Skin and subcutaneous tissue disorders       
Wound Complication, Non-Infectious  1  3/621 (0.48%)  4/624 (0.64%)  4/619 (0.65%) 
Pruritus  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Dermatology/Skin - Other  1  1/621 (0.16%)  1/624 (0.16%)  0/619 (0.00%) 
Ulceration  1  0/621 (0.00%)  1/624 (0.16%)  1/619 (0.16%) 
Vascular disorders       
Inr  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Hemorrhage, Gu - Vagina  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Hemorrhage, Gi - Rectum  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Hemorrhage, Gi - Upper Gi Nos  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Hemorrhage/Pulmonary - Nose  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Hematoma  1  1/621 (0.16%)  0/624 (0.00%)  0/619 (0.00%) 
Hemorrhage, Gi - Lower Gi Nos  1  0/621 (0.00%)  0/624 (0.00%)  2/619 (0.32%) 
Hemorrhage, Gu - Kidney  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Hemorrhage, Gi - Stomach  1  0/621 (0.00%)  1/624 (0.16%)  1/619 (0.16%) 
Hemorrhage, Cns  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Hemorrhage/Bleeding - Other  1  0/621 (0.00%)  0/624 (0.00%)  1/619 (0.16%) 
Artery Injury - Carotid  1  0/621 (0.00%)  1/624 (0.16%)  0/619 (0.00%) 
Thrombosis/Embolism (Vascular Access-Related)  1  2/621 (0.32%)  5/624 (0.80%)  2/619 (0.32%) 
Thrombosis/Thrombus/Embolism  1  17/621 (2.74%)  14/624 (2.24%)  21/619 (3.39%) 
Indicates events were collected by 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 5%
Arm I (Placebo, Paclitaxel, Carboplatin) Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab) Arm III (Paclitaxel, Carboplatin, Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   589/621 (94.85%)   593/624 (95.03%)   588/619 (94.99%) 
Blood and lymphatic system disorders       
Neutrophils  1  589/621 (94.85%)  591/624 (94.71%)  588/619 (94.99%) 
Platelets  1  419/621 (67.47%)  426/624 (68.27%)  435/619 (70.27%) 
Leukocytes  1  578/621 (93.08%)  593/624 (95.03%)  586/619 (94.67%) 
Lymphopenia  1  33/621 (5.31%)  27/624 (4.33%)  32/619 (5.17%) 
Hemoglobin  1  587/621 (94.52%)  574/624 (91.99%)  572/619 (92.41%) 
Edema: Limb  1  115/621 (18.52%)  82/624 (13.14%)  89/619 (14.38%) 
Cardiac disorders       
Palpitations  1  31/621 (4.99%)  22/624 (3.53%)  30/619 (4.85%) 
Hypertension  1  90/621 (14.49%)  149/624 (23.88%)  206/619 (33.28%) 
Hypotension  1  25/621 (4.03%)  25/624 (4.01%)  33/619 (5.33%) 
Ear and labyrinth disorders       
Tinnitus  1  28/621 (4.51%)  18/624 (2.88%)  32/619 (5.17%) 
Endocrine disorders       
Hot Flashes  1  100/621 (16.10%)  70/624 (11.22%)  97/619 (15.67%) 
Eye disorders       
Blurred Vision  1  72/621 (11.59%)  72/624 (11.54%)  94/619 (15.19%) 
Gastrointestinal disorders       
Heartburn  1  71/621 (11.43%)  76/624 (12.18%)  90/619 (14.54%) 
Distention  1  53/621 (8.53%)  38/624 (6.09%)  36/619 (5.82%) 
Taste Alteration  1  75/621 (12.08%)  70/624 (11.22%)  75/619 (12.12%) 
Mucositis (Functional/Sympt) - Oral Cavity  1  58/621 (9.34%)  65/624 (10.42%)  103/619 (16.64%) 
Mucositis (Clinical Exam) - Oral Cavity  1  57/621 (9.18%)  86/624 (13.78%)  97/619 (15.67%) 
Vomiting  1  221/621 (35.59%)  216/624 (34.62%)  236/619 (38.13%) 
Anorexia  1  184/621 (29.63%)  202/624 (32.37%)  202/619 (32.63%) 
Dehydration  1  38/621 (6.12%)  62/624 (9.94%)  52/619 (8.40%) 
Constipation  1  377/621 (60.71%)  351/624 (56.25%)  355/619 (57.35%) 
Nausea  1  388/621 (62.48%)  399/624 (63.94%)  403/619 (65.11%) 
Diarrhea  1  240/621 (38.65%)  265/624 (42.47%)  260/619 (42.00%) 
General disorders       
Sweating  1  36/621 (5.80%)  37/624 (5.93%)  31/619 (5.01%) 
Weight Gain  1  117/621 (18.84%)  106/624 (16.99%)  103/619 (16.64%) 
Fever  1  61/621 (9.82%)  48/624 (7.69%)  74/619 (11.95%) 
Weight Loss  1  76/621 (12.24%)  80/624 (12.82%)  101/619 (16.32%) 
Rigors/Chills  1  36/621 (5.80%)  35/624 (5.61%)  43/619 (6.95%) 
Fatigue  1  515/621 (82.93%)  517/624 (82.85%)  532/619 (85.95%) 
Insomnia  1  125/621 (20.13%)  136/624 (21.79%)  134/619 (21.65%) 
Pain - Other  1  40/621 (6.44%)  41/624 (6.57%)  43/619 (6.95%) 
Pain: Chest /Thorax Nos  1  32/621 (5.15%)  34/624 (5.45%)  30/619 (4.85%) 
Pain: Head/Headache  1  128/621 (20.61%)  142/624 (22.76%)  193/619 (31.18%) 
Pain: Extremity-Limb  1  93/621 (14.98%)  101/624 (16.19%)  142/619 (22.94%) 
Pain: Back  1  99/621 (15.94%)  109/624 (17.47%)  127/619 (20.52%) 
Pain: Joint  1  214/621 (34.46%)  199/624 (31.89%)  245/619 (39.58%) 
Pain: Bone  1  61/621 (9.82%)  52/624 (8.33%)  58/619 (9.37%) 
Pain: Abdominal Pain Nos  1  257/621 (41.38%)  247/624 (39.58%)  249/619 (40.23%) 
Pain: Muscle  1  152/621 (24.48%)  155/624 (24.84%)  169/619 (27.30%) 
Immune system disorders       
Allergic Reaction/Hypersensitivity  1  56/621 (9.02%)  65/624 (10.42%)  68/619 (10.99%) 
Rhinitis  1  67/621 (10.79%)  93/624 (14.90%)  98/619 (15.83%) 
Infections and infestations       
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos  1  38/621 (6.12%)  40/624 (6.41%)  42/619 (6.79%) 
Metabolism and nutrition disorders       
Ast  1  75/621 (12.08%)  63/624 (10.10%)  86/619 (13.89%) 
Proteinuria  1  40/621 (6.44%)  33/624 (5.29%)  59/619 (9.53%) 
Creatinine  1  36/621 (5.80%)  36/624 (5.77%)  53/619 (8.56%) 
Hypoalbuminemia  1  62/621 (9.98%)  71/624 (11.38%)  79/619 (12.76%) 
Alt  1  78/621 (12.56%)  66/624 (10.58%)  76/619 (12.28%) 
Alkaline Phosphatase  1  74/621 (11.92%)  64/624 (10.26%)  83/619 (13.41%) 
Hyponatremia  1  77/621 (12.40%)  75/624 (12.02%)  98/619 (15.83%) 
Hypocalcemia  1  62/621 (9.98%)  58/624 (9.29%)  65/619 (10.50%) 
Hyperkalemia  1  35/621 (5.64%)  32/624 (5.13%)  42/619 (6.79%) 
Hyperglycemia  1  162/621 (26.09%)  152/624 (24.36%)  159/619 (25.69%) 
Hypokalemia  1  103/621 (16.59%)  94/624 (15.06%)  87/619 (14.05%) 
Hypoglycemia  1  29/621 (4.67%)  31/624 (4.97%)  42/619 (6.79%) 
Hypercalcemia  1  28/621 (4.51%)  33/624 (5.29%)  29/619 (4.68%) 
Hypomagnesemia  1  95/621 (15.30%)  104/624 (16.67%)  104/619 (16.80%) 
Musculoskeletal and connective tissue disorders       
Muscle Weakness - Whole Body/Generalized  1  45/621 (7.25%)  55/624 (8.81%)  59/619 (9.53%) 
Muscle Weakness - Extremity-Lower  1  26/621 (4.19%)  31/624 (4.97%)  42/619 (6.79%) 
Nervous system disorders       
Mood Alteration - Depression  1  80/621 (12.88%)  90/624 (14.42%)  101/619 (16.32%) 
Mood Alteration - Anxiety  1  99/621 (15.94%)  92/624 (14.74%)  96/619 (15.51%) 
Memory Impairment  1  27/621 (4.35%)  32/624 (5.13%)  29/619 (4.68%) 
Dizziness  1  104/621 (16.75%)  108/624 (17.31%)  140/619 (22.62%) 
Neuropathy-Sensory  1  435/621 (70.05%)  432/624 (69.23%)  434/619 (70.11%) 
Neuropathy-Motor  1  57/621 (9.18%)  39/624 (6.25%)  48/619 (7.75%) 
Renal and urinary disorders       
Incontinence, Urinary  1  35/621 (5.64%)  36/624 (5.77%)  22/619 (3.55%) 
Urinary Frequency  1  39/621 (6.28%)  46/624 (7.37%)  48/619 (7.75%) 
Respiratory, thoracic and mediastinal disorders       
Nasal/Paranasal Reactions  1  26/621 (4.19%)  46/624 (7.37%)  65/619 (10.50%) 
Voice Changes  1  10/621 (1.61%)  58/624 (9.29%)  73/619 (11.79%) 
Cough  1  112/621 (18.04%)  115/624 (18.43%)  143/619 (23.10%) 
Dyspnea  1  151/621 (24.32%)  180/624 (28.85%)  179/619 (28.92%) 
Skin and subcutaneous tissue disorders       
Nail Changes  1  20/621 (3.22%)  29/624 (4.65%)  42/619 (6.79%) 
Hair Loss/Alopecia (Scalp Or Body)  1  452/621 (72.79%)  459/624 (73.56%)  444/619 (71.73%) 
Bruising  1  31/621 (4.99%)  31/624 (4.97%)  36/619 (5.82%) 
Rash  1  127/621 (20.45%)  123/624 (19.71%)  148/619 (23.91%) 
Dry Skin  1  35/621 (5.64%)  33/624 (5.29%)  36/619 (5.82%) 
Pruritus  1  57/621 (9.18%)  59/624 (9.46%)  66/619 (10.66%) 
Flushing  1  35/621 (5.64%)  33/624 (5.29%)  31/619 (5.01%) 
Dermatology/Skin - Other  1  37/621 (5.96%)  27/624 (4.33%)  33/619 (5.33%) 
Vascular disorders       
Hemorrhage/Pulmonary - Nose  1  60/621 (9.66%)  181/624 (29.01%)  188/619 (30.37%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
The results for both Overall Survival (OS) and Progression Free Survival (PFS) were based on the analysis performed on a data set frozen on August 26, 2011.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Melissa Leventhal
Organization: Gynecologic Oncology Group (GOG) Statistical and Data Center
Phone: 716-845-4030
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00262847     History of Changes
Other Study ID Numbers: NCI-2009-00590
NCI-2009-00590 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000455114
GOG-0218 ( Other Identifier: NRG Oncology )
GOG-0218 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: December 6, 2005
First Posted: December 7, 2005
Results First Submitted: July 9, 2013
Results First Posted: September 18, 2013
Last Update Posted: July 23, 2019