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Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent 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: NCT00565851
Recruitment Status : Active, not recruiting
First Posted : November 30, 2007
Results First Posted : December 14, 2020
Last Update Posted : May 7, 2024
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 Clear Cell Adenocarcinoma
Fallopian Tube Clear Cell Adenocarcinoma
Fallopian Tube Endometrioid Adenocarcinoma
Fallopian Tube Mucinous Adenocarcinoma
Fallopian Tube Serous Adenocarcinoma
Fallopian Tube Transitional Cell Carcinoma
Fallopian Tube Undifferentiated Carcinoma
Mucinous Adenocarcinoma
Ovarian Brenner Tumor
Ovarian Clear Cell Adenocarcinofibroma
Ovarian Clear Cell Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Seromucinous Carcinoma
Ovarian Serous Adenocarcinoma
Ovarian Transitional Cell Carcinoma
Ovarian Undifferentiated Carcinoma
Primary Peritoneal Clear Cell Adenocarcinoma
Primary Peritoneal Endometrioid Adenocarcinoma
Primary Peritoneal Serous Adenocarcinoma
Primary Peritoneal Transitional Cell Carcinoma
Primary Peritoneal Undifferentiated Carcinoma
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Undifferentiated Carcinoma
Interventions Biological: Bevacizumab
Drug: Carboplatin
Drug: Docetaxel
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Paclitaxel
Other: Quality-of-Life Assessment
Enrollment 1052
Recruitment Details At the beginning of the study participants could be randomized to chemotherapy. On August 29, 2011 randomization to chemotherapy ended and participants could only be randomized to surgery.
Pre-assignment Details  
Arm/Group Title Arm I (no Surgery; Carboplatin and Paclitaxel) Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm III (Surgery; Carboplatin and Paclitaxel) Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm V (no Surgery; Carboplatin and Gemcitabine) Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) Arm VII (Surgery; Carboplatin and Gemcitabine) Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Hide Arm/Group Description Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
Period Title: Surgical Assignment
Started 316 456 33 165 6 34 5 37
Randomized - Yes Surgery 0 0 33 165 0 0 5 37
Randomized - no Surgery 33 172 0 0 6 34 0 0
Not Surgical Candidate 283 284 0 0 0 0 0 0
Completed [1] 313 454 31 154 6 34 5 35
Not Completed 3 2 2 11 0 0 0 2
[1]
Includes participants who followed through with surgical assignment
Period Title: Chemotherapy Assignment
Started 316 456 33 165 6 34 5 37
Randomized to Chemo 310 311 27 26 0 0 0 0
Pre-specified Chemo 6 145 6 139 6 34 5 37
Completed 307 433 30 129 6 31 5 34
Not Completed 9 23 3 36 0 3 0 3
Reason Not Completed
Never Initiated Chemotherapy             9             9             3             18             0             2             0             2
Still On Chemotherapy             0             14             0             18             0             1             0             1
Arm/Group Title Arm I (no Surgery; Carboplatin and Paclitaxel) Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm III (Surgery; Carboplatin and Paclitaxel) Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm V (no Surgery; Carboplatin and Gemcitabine) Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)) Arm VII (Surgery; Carboplatin and Gemcitabine) Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)) Total
Hide Arm/Group Description

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.

Carboplatin: Given IV

Docetaxel: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.

Bevacizumab: Given IV

Carboplatin: Given IV

Docetaxel: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

Bevacizumab: Given IV

Carboplatin: Given IV

Docetaxel: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.

Carboplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.

Bevacizumab: Given IV

Carboplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

Carboplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

Bevacizumab: Given IV

Carboplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

 Total of all reporting groups
Overall Number of Baseline Participants 316 456 33 165 6 34 5 37 1052
Hide Baseline Analysis Population Description
All patients enrolled
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 316 participants 456 participants 33 participants 165 participants 6 participants 34 participants 5 participants 37 participants 1052 participants
60.9  (10.0) 59.0  (10.3) 58.7  (10.0) 57.1  (10.5) 72.1  (7.4) 58.7  (8.2) 60.7  (9.3) 61.1  (9.5) 59.4  (10.2)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 316 participants 456 participants 33 participants 165 participants 6 participants 34 participants 5 participants 37 participants 1052 participants
< 40 years
4
   1.3%
14
   3.1%
0
   0.0%
7
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
25
   2.4%
40 - 49 years
40
  12.7%
68
  14.9%
6
  18.2%
37
  22.4%
0
   0.0%
6
  17.6%
1
  20.0%
6
  16.2%
164
  15.6%
50 - 59 years
102
  32.3%
170
  37.3%
11
  33.3%
57
  34.5%
1
  16.7%
14
  41.2%
1
  20.0%
9
  24.3%
365
  34.7%
60 - 69 years
111
  35.1%
143
  31.4%
10
  30.3%
44
  26.7%
0
   0.0%
12
  35.3%
2
  40.0%
13
  35.1%
335
  31.8%
70 - 79 years
52
  16.5%
54
  11.8%
6
  18.2%
19
  11.5%
5
  83.3%
2
   5.9%
1
  20.0%
9
  24.3%
148
  14.1%
≥ 80 years
7
   2.2%
7
   1.5%
0
   0.0%
1
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
15
   1.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 456 participants 33 participants 165 participants 6 participants 34 participants 5 participants 37 participants 1052 participants
Female
316
 100.0%
456
 100.0%
33
 100.0%
165
 100.0%
6
 100.0%
34
 100.0%
5
 100.0%
37
 100.0%
1052
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 456 participants 33 participants 165 participants 6 participants 34 participants 5 participants 37 participants 1052 participants
Hispanic or Latino
14
   4.4%
22
   4.8%
0
   0.0%
6
   3.6%
0
   0.0%
0
   0.0%
0
   0.0%
4
  10.8%
46
   4.4%
Not Hispanic or Latino
272
  86.1%
409
  89.7%
30
  90.9%
155
  93.9%
6
 100.0%
34
 100.0%
5
 100.0%
32
  86.5%
943
  89.6%
Unknown or Not Reported
30
   9.5%
25
   5.5%
3
   9.1%
4
   2.4%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.7%
63
   6.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 316 participants 456 participants 33 participants 165 participants 6 participants 34 participants 5 participants 37 participants 1052 participants
American Indian or Alaska Native
1
   0.3%
5
   1.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
   0.6%
Asian
39
  12.3%
136
  29.8%
6
  18.2%
101
  61.2%
0
   0.0%
14
  41.2%
1
  20.0%
10
  27.0%
307
  29.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   0.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
15
   4.7%
17
   3.7%
1
   3.0%
4
   2.4%
1
  16.7%
3
   8.8%
1
  20.0%
2
   5.4%
44
   4.2%
White
255
  80.7%
294
  64.5%
26
  78.8%
57
  34.5%
5
  83.3%
17
  50.0%
3
  60.0%
25
  67.6%
682
  64.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
   1.9%
3
   0.7%
0
   0.0%
3
   1.8%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
12
   1.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 316 participants 456 participants 33 participants 165 participants 6 participants 34 participants 5 participants 37 participants 1052 participants
South Korea
20
   6.3%
108
  23.7%
4
  12.1%
90
  54.5%
0
   0.0%
11
  32.4%
0
   0.0%
9
  24.3%
242
  23.0%
United States
284
  89.9%
324
  71.1%
29
  87.9%
67
  40.6%
6
 100.0%
23
  67.6%
5
 100.0%
28
  75.7%
766
  72.8%
Japan
12
   3.8%
24
   5.3%
0
   0.0%
7
   4.2%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
43
   4.1%
Russia
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
Histology  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 316 participants 456 participants 33 participants 165 participants 6 participants 34 participants 5 participants 37 participants 1052 participants
Serous
252
  79.7%
383
  84.0%
30
  90.9%
142
  86.1%
5
  83.3%
30
  88.2%
4
  80.0%
35
  94.6%
881
  83.7%
Endometrioid
25
   7.9%
24
   5.3%
0
   0.0%
9
   5.5%
1
  16.7%
2
   5.9%
0
   0.0%
2
   5.4%
63
   6.0%
Clear Cell
13
   4.1%
14
   3.1%
1
   3.0%
5
   3.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
33
   3.1%
Mucinous
2
   0.6%
2
   0.4%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4
   0.4%
Other
24
   7.6%
33
   7.2%
2
   6.1%
9
   5.5%
0
   0.0%
2
   5.9%
1
  20.0%
0
   0.0%
71
   6.7%
1.Primary Outcome
Title To Determine if Surgical Secondary Cytoreduction in Addition to Adjuvant Chemotherapy Increases the Duration of Overall Survival in Patients With Recurrent Platinum Sensitive Epithelial Ovarian Cancer, Peritoneal Primary or Fallopian Tube Cancer
Hide Description The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs > 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
Time Frame The time frame is 82.5 months (median duration of follow-up)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol)
Arm/Group Title No Cytoreductive Surgery Cytoreductive Surgery
Hide Arm/Group Description:
All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
Overall Number of Participants Analyzed 245 240
Median (95% Confidence Interval)
Unit of Measure: Months
64.7
(54.5 to 73.9)
50.6
(44.2 to 59.7)
2.Primary Outcome
Title To Determine if the Addition of Bevacizumab Increases the Duration of Overall Survival Relative to Second-line Paclitaxel and Carboplatin Alone in Patients With Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal Primary or Fallopian Tube Cancer
Hide Description The treatment regimens will be compared with a logrank procedure which includes all of the patients categorized by their randomly assigned treatment. The logrank test will be stratified by the secondary surgical debulking status (randomized to undergo cytoreduction, vs randomized to not undergo secondary cytoreduction vs not a candidate or did not consent to secondary surgical cytoreduction) and the duration of treatment free-interval prior to enrolling onto this study (6-12 months vs > 12 months). The median duration of follow-up is calculated by the reverse Kaplan-Meier method.
Time Frame The time frame is 82.5 months (median duration of follow-up).
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were enrolled between December 10, 2007 and August 26, 2011 and received paclitaxel and carboplatin (with or without bevacizumab) (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
Arm/Group Title Paclitaxel and Carboplatin Chemotherapy Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
Hide Arm/Group Description:
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
Overall Number of Participants Analyzed 337 337
Median (95% Confidence Interval)
Unit of Measure: Months
37.3
(32.6 to 39.7)
42.2
(37.7 to 46.2)
3.Secondary Outcome
Title Progression-free Survival (Chemotherapy Analysis)
Hide Description Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
Time Frame Radiographic assessment of disease was conducted during chemotherapy and then every 6 months during the maintenance / surveillance phase
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who were enrolled and eligible for the chemotherapy analysis (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
Arm/Group Title Paclitaxel and Carboplatin Chemotherapy Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
Hide Arm/Group Description:
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
Overall Number of Participants Analyzed 337 337
Median (95% Confidence Interval)
Unit of Measure: Months
10.4
(9.7 to 11.0)
13.8
(13.0 to 14.7)
4.Secondary Outcome
Title Progression Free Survival (Surgery Analysis)
Hide Description Progression-free survival was defined as the time from randomization to cancer progression as shown on radiography, according to the RECIST version 1.0 criteria, an increase in the CA125 level according to Gynecologic Cancer InterGroup (GCIG) criteria, global deterioration of health, or death from any cause.
Time Frame Radiographic assessment of disease (in patients with measurable and non-measurable disease) was conducted Every three months for two years and then every 6 months after completion of chemotherapy during the maintenance/surveillance phase.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized patients who were eligible for the surgery analysis (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
Arm/Group Title No Cytoreductive Surgery Cytoreductive Surgery
Hide Arm/Group Description:
All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
Overall Number of Participants Analyzed 245 240
Median (95% Confidence Interval)
Unit of Measure: Months
16.2
(14.2 to 19.6)
18.9
(16.8 to 21.0)
5.Secondary Outcome
Title Summary of Adverse Events (CTCAE Version 4.0)
Hide Description Number of treated patients with at least one adverse event reported (assessed by Common Terminology Criteria for Adverse Events (version 4.0))
Time Frame During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title Arm I (no Surgery; Carboplatin and Paclitaxel) Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm III (Surgery; Carboplatin and Paclitaxel) Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm V (no Surgery; Carboplatin and Gemcitabine) Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab)) Arm VII (Surgery; Carboplatin and Gemcitabine) Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab))
Hide Arm/Group Description:

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.

Carboplatin: Given IV

Docetaxel: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study.

Bevacizumab: Given IV

Carboplatin: Given IV

Docetaxel: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

Carboplatin: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

Bevacizumab: Given IV

Carboplatin: Given IV

Docetaxel: Given IV

Laboratory Biomarker Analysis: Correlative studies

Paclitaxel: Given IV

Quality-of-Life Assessment: Ancillary studies

Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.

Carboplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery.

Bevacizumab: Given IV

Carboplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

Carboplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies

Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.

Bevacizumab: Given IV

Carboplatin: Given IV

Gemcitabine Hydrochloride: Given IV

Laboratory Biomarker Analysis: Correlative studies

Quality-of-Life Assessment: Ancillary studies
Overall Number of Participants Analyzed 316 456 33 165 6 34 5 37
Measure Type: Count of Participants
Unit of Measure: Participants
304
  96.2%
376
  82.5%
29
  87.9%
77
  46.7%
3
  50.0%
9
  26.5%
3
  60.0%
9
  24.3%
6.Secondary Outcome
Title Patient Reported Quality of Life (Chemotherapy Analysis)
Hide Description Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
Time Frame 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
Hide Outcome Measure Data
Hide Analysis Population Description
Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
Arm/Group Title Paclitaxel and Carboplatin Chemotherapy Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
Hide Arm/Group Description:
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
Overall Number of Participants Analyzed 298 302
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Prior to cycle 1 (baseline) 75.8  (0.8) 75.3  (0.9)
Prior to cycle 3 74.2  (1.0) 73.4  (0.9)
Prior to cycle 6 73.3  (1.0) 72.3  (1.0)
6 months post cycle 1 77.1  (1.0) 77.2  (1.0)
12 months post cycle 1 77.0  (1.1) 77.8  (1.0)
7.Secondary Outcome
Title Patient Reported Physical Function (Chemotherapy Analysis)
Hide Description Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning Subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning.
Time Frame 1. Prior to cycle 1 (baseline), 2. Prior to cycle 3 (6 weeks post cycle 1), 3. Prior to cycle 6 (15 weeks post cycle 1), 4. 6 months post cycle 1, 5. 12 months post cycle 1.
Hide Outcome Measure Data
Hide Analysis Population Description
Provided baseline and at least one follow-up assessments (data were combined and analyzed according to randomized chemotherapy regimen, regardless of surgical assignment, as pre-specified in the study protocol).
Arm/Group Title Paclitaxel and Carboplatin Chemotherapy Paclitaxel and Carboplatin Chemotherapy With Bevacizumab
Hide Arm/Group Description:
All patients who received paclitaxel and carboplatin chemotherapy and were included in the chemotherapy analysis
All patients who received paclitaxel and carboplatin chemotherapy with bevacizumab followed by bevacizumab maintenance therapy and were included in the chemotherapy analysis
Overall Number of Participants Analyzed 298 302
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Prior to cycle 1 (baseline) 71.5  (1.6) 69.4  (1.7)
Prior to cycle 3 73.2  (2.1) 69.8  (2.1)
Prior to cycle 6 71.5  (2.2) 64.6  (2.2)
6 months post cycle 1 71.6  (2.2) 70.2  (2.1)
12 months post cycle 1 71.8  (2.2) 70.7  (2.2)
8.Secondary Outcome
Title Patient Reported Quality of Life (Surgery Analysis)
Hide Description Patient reported quality of life was measured with the Treatment Outcome Index (TOI) of the Functional Assessment of Cancer Therapy for ovarian cancer (FACT-O TOI). The FACT-O TOI is a scale for assessing general QOL of ovarian cancer patients. It consists of three subscales: Physical Well Being (7 items), Functional Well Being (7 items), and Ovarian Cancer subscale (11 items). Each item in the FACT-O TOI was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). The FACT-O TOI score ranges 0-100 with a large score suggests better QOL.
Time Frame 1. Prior to surgery, 2. 6 weeks post-surgery, 3. 15 weeks post-surgery, 4. 6 months post-surgery, 5. 12 months post-surgery.
Hide Outcome Measure Data
Hide Analysis Population Description
Provided baseline and at least one follow-up assessment (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
Arm/Group Title No Cytoreductive Surgery Cytoreductive Surgery
Hide Arm/Group Description:
All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
Overall Number of Participants Analyzed 215 206
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Prior to surgery 74.5  (1.0) 74.2  (1.0)
6 weeks post-surgery 69.3  (1.3) 68.4  (1.3)
15 weeks post-surgery 68.7  (1.3) 68.8  (1.3)
6 months post-surgery 72.6  (1.3) 73.5  (1.3)
12 months post-surgery 74.0  (1.4) 75.6  (1.3)
9.Secondary Outcome
Title Patient Reported Physical Functioning (Surgery Analysis)
Hide Description Patient reported physical functioning was measured with physical functioning subscale of the RAND SF-36. The Physical Functioning subscale consists of 10 items concerning activities of daily living: walking, climbing stairs, bathing, dressing, and performance of physical activities. Each item is rated on a three-point scale of limitation of activity due to the patients' health from 1=limited a lot to 3=not limited. The total PF score is the summation of item scores and then rescaled to 0-100. A larger score suggests better physical functioning. This measure was completed by US patients only.
Time Frame 1. Prior to surgery (baseline), 2. 6 weeks post-surgery, 3. 15 weeks post-surgery 4. 6 months post-surgery, 5. 12 months post-surgery
Hide Outcome Measure Data
Hide Analysis Population Description
US patients who provided baseline and ≥ 1 follow-up assessments (data were combined and analyzed according to randomized surgical assignment, regardless of chemotherapy regimen, as pre-specified in the study protocol).
Arm/Group Title No Cytoreductive Surgery Cytoreductive Surgery
Hide Arm/Group Description:
All patients enrolled in the study who did not receive cytoreductive surgery and included in the surgery analysis
All patients enrolled in the study who received secondary cytoreductive surgery and were included in the surgery analysis
Overall Number of Participants Analyzed 104 113
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
Prior to surgery (baseline) 73.4  (2.3) 71.7  (2.3)
6 weeks post-surgery 73.2  (2.1) 69.8  (2.1)
15 weeks post-surgery 71.5  (2.2) 64.6  (2.2)
6 months post-surgery 71.6  (2.2) 70.2  (2.1)
12 months post-surgery 71.8  (2.2) 70.7  (2.2)
Time Frame During treatment period and up to 100 days after stopping the study treatment, a median duration of 82.5 months.
Adverse Event Reporting Description Eligible and treated participants were affected if they experienced grade 1 - 5 adverse event. Adverse events were not collected in a manner that allow them to be attributed to an intervention (i.e. surgery or chemotherapy).
 
Arm/Group Title Arm I (no Surgery; Carboplatin and Paclitaxel) Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm III (Surgery; Carboplatin and Paclitaxel) Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm V (no Surgery; Carboplatin and Gemcitabine) Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) Arm VII (Surgery; Carboplatin and Gemcitabine) Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Hide Arm/Group Description Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Patients receive chemotherapy as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days. Patients are not in secondary cytoreductive surgery portion of study. Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Patients receive paclitaxel IV over 3 hours or docetaxel IV over 1 hour and carboplatin over 30 minutes on day 1. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients do not receive secondary cytoreductive surgery. Patients receive carboplatin as in arm I. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery. Patients receive carboplatin as in arm I and bevacizumab IV over 30-90 minutes on day 1. Patients receive gemcitabine. Treatment repeats every 21 days. Patients receive secondary cytoreductive surgery.
All-Cause Mortality
Arm I (no Surgery; Carboplatin and Paclitaxel) Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm III (Surgery; Carboplatin and Paclitaxel) Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm V (no Surgery; Carboplatin and Gemcitabine) Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) Arm VII (Surgery; Carboplatin and Gemcitabine) Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   253/316 (80.06%)   299/456 (65.57%)   28/33 (84.85%)   56/165 (33.94%)   4/6 (66.67%)   14/34 (41.18%)   4/5 (80.00%)   21/37 (56.76%) 
Hide Serious Adverse Events
Arm I (no Surgery; Carboplatin and Paclitaxel) Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm III (Surgery; Carboplatin and Paclitaxel) Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm V (no Surgery; Carboplatin and Gemcitabine) Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) Arm VII (Surgery; Carboplatin and Gemcitabine) Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/316 (11.71%)   104/456 (22.81%)   1/33 (3.03%)   24/165 (14.55%)   0/6 (0.00%)   1/34 (2.94%)   2/5 (40.00%)   2/37 (5.41%) 
Blood and lymphatic system disorders                 
Myelodysplasia * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Neutrophils * 1  3/316 (0.95%)  4/456 (0.88%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Platelets * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Blood/Bone Marrow - Other * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Leukocytes * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cardiac disorders                 
S/N Arrhythmia: Atrial Fibrillation * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cardiac Ischemia/Infarction * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypertension * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Lt Ventricular Systolic Dysfunction * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypotension * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cardipulmonary Arrest * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Eye disorders                 
Blurred Vision * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Gastrointestinal disorders                 
Fistula, Gi - Colon/Cecum/Appendix * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Obstruction, Gi - Ileum * 1  2/316 (0.63%)  1/456 (0.22%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Perforation, Gi - Colon * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Dental: Periodontal * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Fistula, Gi - Small Bowel Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Obstruction, Gi - Colon * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  0/37 (0.00%) 
Perforation, Gi - Cecum * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ulcer,gi - Stomach * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ileus * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Obstruction, Gi - Small Bowel Nos * 1  1/316 (0.32%)  6/456 (1.32%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Colitis * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Perforation, Gi - Small Bowel Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Vomiting * 1  2/316 (0.63%)  1/456 (0.22%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Dehydration * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Constipation * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Nausea * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Diarrhea * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
General disorders                 
Death No Ctcae Term - Disease Progression Nos * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Death No Ctcae Term - Death Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Death No Ctcae Term - Sudden Death * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain - Other * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Chest /Thorax Nos * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Head/Headache * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Back * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Abdominal Pain Nos * 1  0/316 (0.00%)  5/456 (1.10%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hepatobiliary disorders                 
Hepatobiliary/Pancreas - Other * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Immune system disorders                 
Allergic Reaction/Hypersensitivity * 1  1/316 (0.32%)  8/456 (1.75%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  0/37 (0.00%) 
Infections and infestations                 
Inf W/Gr 3 Or 4 Anc: Blood * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Foreign Body * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Febrile Neutropenia * 1  7/316 (2.22%)  14/456 (3.07%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  2/316 (0.63%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Infection - Other * 1  0/316 (0.00%)  1/456 (0.22%)  1/33 (3.03%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Liver * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Urinary Tract Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Foreign Body * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Catheter-Related * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Eye Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Catheter-Related * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Metabolism and nutrition disorders                 
Cholesterol,serum High * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Alt * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hyponatremia * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hyperglycemia * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypokalemia * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Musculoskeletal and connective tissue disorders                 
Musculoskeletal/St: Other * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Muscle Weakness - Right-Sided * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
2nd Mal: Poss. Related To Cancer Rx * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Nervous system disorders                 
Syncope * 1  2/316 (0.63%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Neurology - Other * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Mood Alteration - Depression * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cns Ischemia * 1  1/316 (0.32%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Confusion * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Memory Impairment * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Neuropathy-Sensory * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Neuropathy-Motor * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Renal and urinary disorders                 
Renal Failure * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Reproductive system and breast disorders                 
Vaginal Dryness * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Hypoxia * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Dyspnea * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Skin and subcutaneous tissue disorders                 
Ulceration * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Vascular disorders                 
Hemorrhage, Gi - Rectum * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gi - Upper Gi Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage/Pulmonary - Nose * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gi - Stomach * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Cns * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Vascular - Other * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Thrombosis/Thrombus/Embolism * 1  4/316 (1.27%)  6/456 (1.32%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (no Surgery; Carboplatin and Paclitaxel) Arm II (no Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm III (Surgery; Carboplatin and Paclitaxel) Arm IV (Surgery; Carboplatin, Paclitaxel and Bevacizumab) Arm V (no Surgery; Carboplatin and Gemcitabine) Arm VI (no Surgery; Carboplatin, Gemcitabine and Bevacizumab) Arm VII (Surgery; Carboplatin and Gemcitabine) Arm VIII (Surgery; Carboplatin, Gemcitabine and Bevacizumab)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   304/316 (96.20%)   376/456 (82.46%)   29/33 (87.88%)   77/165 (46.67%)   3/6 (50.00%)   9/34 (26.47%)   3/5 (60.00%)   9/37 (24.32%) 
Blood and lymphatic system disorders                 
Neutrophils * 1  282/316 (89.24%)  363/456 (79.61%)  28/33 (84.85%)  72/165 (43.64%)  3/6 (50.00%)  7/34 (20.59%)  3/5 (60.00%)  8/37 (21.62%) 
Platelets * 1  173/316 (54.75%)  264/456 (57.89%)  22/33 (66.67%)  52/165 (31.52%)  3/6 (50.00%)  7/34 (20.59%)  3/5 (60.00%)  8/37 (21.62%) 
Blood/Bone Marrow - Other * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Leukocytes * 1  276/316 (87.34%)  350/456 (76.75%)  28/33 (84.85%)  67/165 (40.61%)  3/6 (50.00%)  9/34 (26.47%)  3/5 (60.00%)  9/37 (24.32%) 
Lymphopenia * 1  21/316 (6.65%)  31/456 (6.80%)  1/33 (3.03%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemoglobin * 1  279/316 (88.29%)  316/456 (69.30%)  29/33 (87.88%)  67/165 (40.61%)  3/6 (50.00%)  9/34 (26.47%)  3/5 (60.00%)  9/37 (24.32%) 
Lymphedema-Related Fibrosis * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Lymphatics - Other * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Edema: Trunk/Genital * 1  1/316 (0.32%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Edema: Limb * 1  40/316 (12.66%)  44/456 (9.65%)  3/33 (9.09%)  8/165 (4.85%)  1/6 (16.67%)  1/34 (2.94%)  0/5 (0.00%)  3/37 (8.11%) 
Edema: Head And Neck * 1  1/316 (0.32%)  8/456 (1.75%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cardiac disorders                 
Prolonged Qtc Interval * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
S/N Arrhythmia: Atrial Fibrillation * 1  2/316 (0.63%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Palpitations * 1  12/316 (3.80%)  19/456 (4.17%)  1/33 (3.03%)  4/165 (2.42%)  1/6 (16.67%)  0/34 (0.00%)  1/5 (20.00%)  0/37 (0.00%) 
Cardiac Arrhythmia - Other * 1  1/316 (0.32%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ventricular Arrhythmia - Tachycardia * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
S/N Arrhythmia: Sinus Tachycardia * 1  5/316 (1.58%)  15/456 (3.29%)  1/33 (3.03%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Supraventricular Tachycardia * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
S/N Arrhythmia: Sinus Bradycardia * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ventricular Arrhythmia - Pvcs * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ventricular Arrhythmia - Fibrillation * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cardiac Ischemia/Infarction * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypertension * 1  10/316 (3.16%)  147/456 (32.24%)  0/33 (0.00%)  22/165 (13.33%)  0/6 (0.00%)  1/34 (2.94%)  1/5 (20.00%)  5/37 (13.51%) 
Restrictive Cardiomyopathy * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Left Venticular Diastolic Dysfunction * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cardiac General - Other * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cardiac Troponin I (Ctni) * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypotension * 1  3/316 (0.95%)  12/456 (2.63%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cardipulmonary Arrest * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ear and labyrinth disorders                 
Otitis Middle Ear * 1  1/316 (0.32%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Auditory/Ear - Other * 1  1/316 (0.32%)  3/456 (0.66%)  1/33 (3.03%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hearing (Without Monitoring Program) * 1  5/316 (1.58%)  12/456 (2.63%)  1/33 (3.03%)  0/165 (0.00%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Tinnitus * 1  15/316 (4.75%)  23/456 (5.04%)  1/33 (3.03%)  2/165 (1.21%)  1/6 (16.67%)  0/34 (0.00%)  1/5 (20.00%)  0/37 (0.00%) 
Hearing (Monitoring Program) * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Endocrine disorders                 
Hot Flashes * 1  27/316 (8.54%)  45/456 (9.87%)  5/33 (15.15%)  8/165 (4.85%)  0/6 (0.00%)  2/34 (5.88%)  0/5 (0.00%)  1/37 (2.70%) 
Diabetes * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Adh Secrection Abnormality * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypoparathyroidism * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Adrenal Insufficiency * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hyperthyroidism * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Endocrine - Other * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypothyroidism * 1  1/316 (0.32%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Eye disorders                 
Ocular/Visual - Other * 1  6/316 (1.90%)  11/456 (2.41%)  1/33 (3.03%)  2/165 (1.21%)  1/6 (16.67%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Scleral Necrosis * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Watery Eye * 1  7/316 (2.22%)  7/456 (1.54%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Dry Eye * 1  1/316 (0.32%)  5/456 (1.10%)  1/33 (3.03%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ocular Surface Disease * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cataract * 1  0/316 (0.00%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Photophobia * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Flashing Lights/Floaters * 1  6/316 (1.90%)  19/456 (4.17%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Diplopia * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Blurred Vision * 1  36/316 (11.39%)  55/456 (12.06%)  2/33 (6.06%)  4/165 (2.42%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  1/37 (2.70%) 
Eyelid Dysfunction * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  1/6 (16.67%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Gastrointestinal disorders                 
Proctitis * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Salivary Gland Changes * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Flatulence * 1  5/316 (1.58%)  11/456 (2.41%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Ulcer,gi - Esophagus * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Perforation, Gi - Colon * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Dental: Periodontal * 1  0/316 (0.00%)  10/456 (2.19%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Fistula, Gi - Small Bowel Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Fistula, Gi - Rectum * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Gastritis * 1  4/316 (1.27%)  5/456 (1.10%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Esophagitis * 1  2/316 (0.63%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Perforation, Gi - Cecum * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Hemorrhoids * 1  1/316 (0.32%)  22/456 (4.82%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Heartburn * 1  28/316 (8.86%)  51/456 (11.18%)  3/33 (9.09%)  8/165 (4.85%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Mucositis (Functional/Sympt) - Esophagus * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ulcer,gi - Stomach * 1  0/316 (0.00%)  5/456 (1.10%)  1/33 (3.03%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Dental: Teeth * 1  0/316 (0.00%)  7/456 (1.54%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Mucositis (Functional/Sympt) - Trachea * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ascites * 1  1/316 (0.32%)  4/456 (0.88%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Leak, Gi - Rectum * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ileus * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Dysphagia * 1  6/316 (1.90%)  20/456 (4.39%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Distention * 1  18/316 (5.70%)  27/456 (5.92%)  3/33 (9.09%)  6/165 (3.64%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Taste Alteration * 1  36/316 (11.39%)  46/456 (10.09%)  3/33 (9.09%)  10/165 (6.06%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Incontinence, Anal * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Dry Mouth * 1  6/316 (1.90%)  17/456 (3.73%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Mucositis (Functional/Sympt) - Stomach * 1  2/316 (0.63%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Mucositis (Functional/Sympt) - Rectum * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Mucositis (Functional/Sympt) - Oral Cavity * 1  32/316 (10.13%)  69/456 (15.13%)  2/33 (6.06%)  8/165 (4.85%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Obstruction, Gi - Small Bowel Nos * 1  3/316 (0.95%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Fistula, Gi - Oral Cavity * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Colitis * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Perforation, Gi - Small Bowel Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Mucositis (Clinical Exam) - Oral Cavity * 1  23/316 (7.28%)  67/456 (14.69%)  0/33 (0.00%)  14/165 (8.48%)  0/6 (0.00%)  4/34 (11.76%)  1/5 (20.00%)  0/37 (0.00%) 
Mucositis (Clinical Exam) - Larynx * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Vomiting * 1  75/316 (23.73%)  125/456 (27.41%)  7/33 (21.21%)  16/165 (9.70%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  4/37 (10.81%) 
Anorexia * 1  78/316 (24.68%)  129/456 (28.29%)  10/33 (30.30%)  19/165 (11.52%)  0/6 (0.00%)  3/34 (8.82%)  1/5 (20.00%)  1/37 (2.70%) 
Dehydration * 1  12/316 (3.80%)  20/456 (4.39%)  1/33 (3.03%)  5/165 (3.03%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  1/37 (2.70%) 
Constipation * 1  167/316 (52.85%)  193/456 (42.32%)  20/33 (60.61%)  39/165 (23.64%)  2/6 (33.33%)  2/34 (5.88%)  1/5 (20.00%)  3/37 (8.11%) 
Stricture, Gi - Stomach * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Nausea * 1  182/316 (57.59%)  223/456 (48.90%)  19/33 (57.58%)  42/165 (25.45%)  1/6 (16.67%)  3/34 (8.82%)  1/5 (20.00%)  6/37 (16.22%) 
Gastrointestinal - Other * 1  3/316 (0.95%)  10/456 (2.19%)  1/33 (3.03%)  1/165 (0.61%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Diarrhea * 1  98/316 (31.01%)  148/456 (32.46%)  11/33 (33.33%)  30/165 (18.18%)  0/6 (0.00%)  3/34 (8.82%)  0/5 (0.00%)  4/37 (10.81%) 
Ulcer,gi - Small Bowel Nos * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Mucositis (Clinical Exam) - Pharynx * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
General disorders                 
Constitutional Symptoms - Other * 1  0/316 (0.00%)  5/456 (1.10%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Sweating * 1  10/316 (3.16%)  8/456 (1.75%)  2/33 (6.06%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Weight Gain * 1  18/316 (5.70%)  27/456 (5.92%)  1/33 (3.03%)  6/165 (3.64%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Fever * 1  31/316 (9.81%)  45/456 (9.87%)  1/33 (3.03%)  13/165 (7.88%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Weight Loss * 1  12/316 (3.80%)  54/456 (11.84%)  1/33 (3.03%)  6/165 (3.64%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  0/37 (0.00%) 
Rigors/Chills * 1  7/316 (2.22%)  14/456 (3.07%)  1/33 (3.03%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Fatigue * 1  245/316 (77.53%)  297/456 (65.13%)  25/33 (75.76%)  48/165 (29.09%)  2/6 (33.33%)  5/34 (14.71%)  3/5 (60.00%)  5/37 (13.51%) 
Insomnia * 1  47/316 (14.87%)  67/456 (14.69%)  4/33 (12.12%)  13/165 (7.88%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  3/37 (8.11%) 
Pain - Other * 1  6/316 (1.90%)  22/456 (4.82%)  2/33 (6.06%)  3/165 (1.82%)  1/6 (16.67%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Urethra * 1  3/316 (0.95%)  3/456 (0.66%)  1/33 (3.03%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Perineum * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Pelvis * 1  10/316 (3.16%)  11/456 (2.41%)  2/33 (6.06%)  4/165 (2.42%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Breast * 1  4/316 (1.27%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Vagina * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Chest /Thorax Nos * 1  6/316 (1.90%)  23/456 (5.04%)  1/33 (3.03%)  5/165 (3.03%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Pain: Chest Wall * 1  10/316 (3.16%)  17/456 (3.73%)  1/33 (3.03%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Throat/Pharynx/Larynx * 1  9/316 (2.85%)  31/456 (6.80%)  1/33 (3.03%)  4/165 (2.42%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  1/37 (2.70%) 
Pain: Pleura * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Larynx * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Eye * 1  0/316 (0.00%)  6/456 (1.32%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Head/Headache * 1  59/316 (18.67%)  142/456 (31.14%)  7/33 (21.21%)  19/165 (11.52%)  2/6 (33.33%)  4/34 (11.76%)  1/5 (20.00%)  2/37 (5.41%) 
Pain: Neck * 1  1/316 (0.32%)  33/456 (7.24%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Pain: Extremity-Limb * 1  41/316 (12.97%)  97/456 (21.27%)  7/33 (21.21%)  13/165 (7.88%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  1/37 (2.70%) 
Pain: Buttock * 1  1/316 (0.32%)  5/456 (1.10%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Back * 1  35/316 (11.08%)  65/456 (14.25%)  3/33 (9.09%)  13/165 (7.88%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  2/37 (5.41%) 
Pain: Joint * 1  99/316 (31.33%)  166/456 (36.40%)  4/33 (12.12%)  28/165 (16.97%)  1/6 (16.67%)  2/34 (5.88%)  0/5 (0.00%)  3/37 (8.11%) 
Pain: Bone * 1  19/316 (6.01%)  33/456 (7.24%)  3/33 (9.09%)  8/165 (4.85%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Kidney * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Bladder * 1  1/316 (0.32%)  4/456 (0.88%)  2/33 (6.06%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Pain Nos * 1  4/316 (1.27%)  8/456 (1.75%)  0/33 (0.00%)  7/165 (4.24%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Stomach * 1  3/316 (0.95%)  9/456 (1.97%)  1/33 (3.03%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Rectum * 1  1/316 (0.32%)  6/456 (1.32%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Oral Cavity * 1  2/316 (0.63%)  13/456 (2.85%)  1/33 (3.03%)  4/165 (2.42%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Esophagus * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Dental/Teeth/Peridontal * 1  0/316 (0.00%)  9/456 (1.97%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  2/37 (5.41%) 
Pain: Abdominal Pain Nos * 1  84/316 (26.58%)  127/456 (27.85%)  16/33 (48.48%)  36/165 (21.82%)  2/6 (33.33%)  2/34 (5.88%)  1/5 (20.00%)  4/37 (10.81%) 
Pain: Scalp * 1  1/316 (0.32%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Oral - Gums * 1  0/316 (0.00%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Skin * 1  0/316 (0.00%)  2/456 (0.44%)  1/33 (3.03%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Lip * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Middle Ear * 1  5/316 (1.58%)  8/456 (1.75%)  1/33 (3.03%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Pain: External Ear * 1  1/316 (0.32%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Cardiac/ Heart * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  0/37 (0.00%) 
Pain: Face * 1  0/316 (0.00%)  6/456 (1.32%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Tumor * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Muscle * 1  55/316 (17.41%)  107/456 (23.46%)  4/33 (12.12%)  23/165 (13.94%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Pain: Anus * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Neuralgia * 1  0/316 (0.00%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  1/6 (16.67%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pain: Sinus * 1  0/316 (0.00%)  6/456 (1.32%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Cytokine Release Syndrome * 1  4/316 (1.27%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Flu-Like Syndrome * 1  1/316 (0.32%)  17/456 (3.73%)  0/33 (0.00%)  4/165 (2.42%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hepatobiliary disorders                 
Hepatobiliary/Pancreas - Other * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cholecystitis * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Liver Dysfunction * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Immune system disorders                 
Allergy/Immunology - Other * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Allergic Reaction/Hypersensitivity * 1  76/316 (24.05%)  86/456 (18.86%)  6/33 (18.18%)  16/165 (9.70%)  1/6 (16.67%)  0/34 (0.00%)  1/5 (20.00%)  3/37 (8.11%) 
Vasculitis * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Rhinitis * 1  13/316 (4.11%)  62/456 (13.60%)  1/33 (3.03%)  8/165 (4.85%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Autoimmune Reaction * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Infections and infestations                 
Inf W/Gr 3 Or 4 Anc: Blood * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis) * 1  2/316 (0.63%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Middle Ear * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva * 1  1/316 (0.32%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos * 1  10/316 (3.16%)  20/456 (4.39%)  1/33 (3.03%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Nose * 1  2/316 (0.63%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) * 1  4/316 (1.27%)  6/456 (1.32%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Larynx * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Meninges * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Brain * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Joint * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Blood * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Wound * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums * 1  1/316 (0.32%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos * 1  2/316 (0.63%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) * 1  6/316 (1.90%)  7/456 (1.54%)  1/33 (3.03%)  1/165 (0.61%)  1/6 (16.67%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related * 1  0/316 (0.00%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Febrile Neutropenia * 1  2/316 (0.63%)  9/456 (1.97%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral * 1  0/316 (0.00%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Lung (Pneumonia) * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Nose * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Sinus * 1  1/316 (0.32%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth * 1  0/316 (0.00%)  7/456 (1.54%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Colon * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos * 1  19/316 (6.01%)  25/456 (5.48%)  3/33 (9.09%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails) * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Stomach * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Infection - Other * 1  7/316 (2.22%)  14/456 (3.07%)  1/33 (3.03%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Bladder (Urinary) * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia * 1  2/316 (0.63%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Colitis, Infectious (Eg.C. Difficile) * 1  1/316 (0.32%)  4/456 (0.88%)  1/33 (3.03%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Conjunctiva * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus * 1  5/316 (1.58%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Appendix * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Inf Unknown Anc: Upper Airway Nos * 1  0/316 (0.00%)  7/456 (1.54%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina * 1  0/316 (0.00%)  10/456 (2.19%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus * 1  5/316 (1.58%)  20/456 (4.39%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Pharynx * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Bronchus * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Eye Nos * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Soft Tissue Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Urinary Tract Nos * 1  6/316 (1.90%)  10/456 (2.19%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Bladder (Urinary) * 1  2/316 (0.63%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Catheter-Related * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Inf Unknown Anc: Oral Cavity-Gums * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Dental-Tooth * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Abdomen Nos * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Skin (Cellulitis) * 1  1/316 (0.32%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Inf Unknown Anc: Middle Ear * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Vulva * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Inf W/Gr 3 Or 4 Anc: Vagina * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos * 1  4/316 (1.27%)  6/456 (1.32%)  0/33 (0.00%)  4/165 (2.42%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Sinus * 1  1/316 (0.32%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Pharynx * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Nose * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia) * 1  2/316 (0.63%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Bronchus * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Joint * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder * 1  3/316 (0.95%)  8/456 (1.75%)  1/33 (3.03%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos * 1  6/316 (1.90%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Inf W/Nml Or Gr 1 Or 2 Anc: External Ear * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Metabolism and nutrition disorders                 
Ast * 1  30/316 (9.49%)  62/456 (13.60%)  2/33 (6.06%)  6/165 (3.64%)  0/6 (0.00%)  2/34 (5.88%)  1/5 (20.00%)  3/37 (8.11%) 
Gfr * 1  2/316 (0.63%)  7/456 (1.54%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Metabolic/Laboratory - Other * 1  10/316 (3.16%)  14/456 (3.07%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cholesterol,serum High * 1  2/316 (0.63%)  17/456 (3.73%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  0/37 (0.00%) 
Proteinuria * 1  3/316 (0.95%)  70/456 (15.35%)  0/33 (0.00%)  17/165 (10.30%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Creatinine * 1  17/316 (5.38%)  52/456 (11.40%)  1/33 (3.03%)  5/165 (3.03%)  0/6 (0.00%)  2/34 (5.88%)  2/5 (40.00%)  1/37 (2.70%) 
Hypoalbuminemia * 1  20/316 (6.33%)  43/456 (9.43%)  1/33 (3.03%)  4/165 (2.42%)  0/6 (0.00%)  3/34 (8.82%)  1/5 (20.00%)  0/37 (0.00%) 
Ggt * 1  2/316 (0.63%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Alt * 1  27/316 (8.54%)  41/456 (8.99%)  1/33 (3.03%)  5/165 (3.03%)  0/6 (0.00%)  0/34 (0.00%)  2/5 (40.00%)  3/37 (8.11%) 
Alkaline Phosphatase * 1  22/316 (6.96%)  35/456 (7.68%)  2/33 (6.06%)  1/165 (0.61%)  0/6 (0.00%)  1/34 (2.94%)  1/5 (20.00%)  3/37 (8.11%) 
Bilirubin * 1  3/316 (0.95%)  12/456 (2.63%)  1/33 (3.03%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Lipase * 1  1/316 (0.32%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypermagnesemia * 1  1/316 (0.32%)  13/456 (2.85%)  1/33 (3.03%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypophosphatemia * 1  13/316 (4.11%)  22/456 (4.82%)  3/33 (9.09%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hyponatremia * 1  19/316 (6.01%)  60/456 (13.16%)  1/33 (3.03%)  2/165 (1.21%)  0/6 (0.00%)  1/34 (2.94%)  1/5 (20.00%)  2/37 (5.41%) 
Hyperuricemia * 1  0/316 (0.00%)  5/456 (1.10%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypertriglyceridemia * 1  3/316 (0.95%)  11/456 (2.41%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  0/37 (0.00%) 
Cpk * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Bicarbonate, Serum-Low * 1  3/316 (0.95%)  7/456 (1.54%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Amylase * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypernatremia * 1  5/316 (1.58%)  5/456 (1.10%)  1/33 (3.03%)  2/165 (1.21%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  1/37 (2.70%) 
Hypocalcemia * 1  16/316 (5.06%)  48/456 (10.53%)  1/33 (3.03%)  6/165 (3.64%)  0/6 (0.00%)  2/34 (5.88%)  1/5 (20.00%)  1/37 (2.70%) 
Hyperkalemia * 1  10/316 (3.16%)  26/456 (5.70%)  0/33 (0.00%)  8/165 (4.85%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  1/37 (2.70%) 
Hyperglycemia * 1  74/316 (23.42%)  111/456 (24.34%)  5/33 (15.15%)  10/165 (6.06%)  1/6 (16.67%)  3/34 (8.82%)  2/5 (40.00%)  2/37 (5.41%) 
Hypokalemia * 1  33/316 (10.44%)  48/456 (10.53%)  3/33 (9.09%)  7/165 (4.24%)  0/6 (0.00%)  2/34 (5.88%)  1/5 (20.00%)  1/37 (2.70%) 
Hypoglycemia * 1  7/316 (2.22%)  21/456 (4.61%)  1/33 (3.03%)  3/165 (1.82%)  0/6 (0.00%)  2/34 (5.88%)  1/5 (20.00%)  0/37 (0.00%) 
Hypercalcemia * 1  6/316 (1.90%)  20/456 (4.39%)  0/33 (0.00%)  5/165 (3.03%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hypomagnesemia * 1  51/316 (16.14%)  104/456 (22.81%)  8/33 (24.24%)  13/165 (7.88%)  0/6 (0.00%)  1/34 (2.94%)  1/5 (20.00%)  1/37 (2.70%) 
Musculoskeletal and connective tissue disorders                 
Musculoskeletal/St: Other * 1  1/316 (0.32%)  11/456 (2.41%)  1/33 (3.03%)  1/165 (0.61%)  0/6 (0.00%)  2/34 (5.88%)  0/5 (0.00%)  0/37 (0.00%) 
Soft Tissue Necrosis - Abdomen * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Osteoporosis * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Joint-Function * 1  2/316 (0.63%)  4/456 (0.88%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Joint Effusion * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Fracture * 1  1/316 (0.32%)  2/456 (0.44%)  1/33 (3.03%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Extremity-Upper (Function) * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Gait/Walking * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cervical Spine Rom * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Arthritis * 1  3/316 (0.95%)  20/456 (4.39%)  1/33 (3.03%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Muscle Weakness - Whole Body/Generalized * 1  15/316 (4.75%)  32/456 (7.02%)  4/33 (12.12%)  6/165 (3.64%)  0/6 (0.00%)  2/34 (5.88%)  0/5 (0.00%)  1/37 (2.70%) 
Muscle Weakness - Right-Sided * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Muscle Weakness - Left-Sided * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Muscle Weakness - Extremity-Upper * 1  1/316 (0.32%)  3/456 (0.66%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Muscle Weakness - Extremity-Lower * 1  8/316 (2.53%)  15/456 (3.29%)  4/33 (12.12%)  2/165 (1.21%)  0/6 (0.00%)  2/34 (5.88%)  0/5 (0.00%)  0/37 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
2nd Mal: Poss. Related To Cancer Rx * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Nervous system disorders                 
Syncope * 1  3/316 (0.95%)  8/456 (1.75%)  1/33 (3.03%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Involuntary Movement * 1  5/316 (1.58%)  2/456 (0.44%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Neurology - Other * 1  1/316 (0.32%)  5/456 (1.10%)  0/33 (0.00%)  0/165 (0.00%)  1/6 (16.67%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Mental Status * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Encephalopathy * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Mood Alteration - Depression * 1  42/316 (13.29%)  51/456 (11.18%)  5/33 (15.15%)  12/165 (7.27%)  1/6 (16.67%)  1/34 (2.94%)  0/5 (0.00%)  1/37 (2.70%) 
Mood Alteration - Anxiety * 1  39/316 (12.34%)  57/456 (12.50%)  3/33 (9.09%)  13/165 (7.88%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Mood Alteration - Agitation * 1  4/316 (1.27%)  1/456 (0.22%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Tremor * 1  4/316 (1.27%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Speech Impairment * 1  0/316 (0.00%)  5/456 (1.10%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Seizure * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Irritability * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Somnolence * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cognitive Disturbance * 1  1/316 (0.32%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cns Ischemia * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ataxia * 1  2/316 (0.63%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  1/6 (16.67%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Confusion * 1  1/316 (0.32%)  6/456 (1.32%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Memory Impairment * 1  7/316 (2.22%)  16/456 (3.51%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Dizziness * 1  24/316 (7.59%)  51/456 (11.18%)  4/33 (12.12%)  8/165 (4.85%)  1/6 (16.67%)  2/34 (5.88%)  0/5 (0.00%)  0/37 (0.00%) 
Neuropathy,cranial - Cn Xii Motor-Tongue * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Neuropathy,cranial - Cn Viii Hearing/Balance * 1  2/316 (0.63%)  1/456 (0.22%)  1/33 (3.03%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Neuropathy,cranial - Cn Vii Motor-Face * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Neuropathy,cranial - Cn Iii Pupil * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Neuropathy,cranial - Cn I Smell * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Neuropathy-Sensory * 1  237/316 (75.00%)  272/456 (59.65%)  18/33 (54.55%)  55/165 (33.33%)  3/6 (50.00%)  4/34 (11.76%)  1/5 (20.00%)  5/37 (13.51%) 
Neuropathy-Motor * 1  15/316 (4.75%)  14/456 (3.07%)  2/33 (6.06%)  5/165 (3.03%)  1/6 (16.67%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Renal and urinary disorders                 
Renal/Genitourinary - Other * 1  2/316 (0.63%)  10/456 (2.19%)  1/33 (3.03%)  0/165 (0.00%)  1/6 (16.67%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cystitis * 1  0/316 (0.00%)  10/456 (2.19%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Urinary Color Change * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Urinary Retention * 1  2/316 (0.63%)  6/456 (1.32%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Obstruction, Gu - Urethra * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Obstruction, Gu - Ureter * 1  3/316 (0.95%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Incontinence, Urinary * 1  16/316 (5.06%)  20/456 (4.39%)  1/33 (3.03%)  3/165 (1.82%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Bladder Spasm * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Renal Failure * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  0/37 (0.00%) 
Urinary Frequency * 1  25/316 (7.91%)  35/456 (7.68%)  3/33 (9.09%)  4/165 (2.42%)  1/6 (16.67%)  1/34 (2.94%)  1/5 (20.00%)  0/37 (0.00%) 
Reproductive system and breast disorders                 
Libido * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Vaginal Dryness * 1  4/316 (1.27%)  7/456 (1.54%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Sexual/Reproductive Function: Other * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Vaginitis * 1  2/316 (0.63%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Vaginal Discharge * 1  4/316 (1.27%)  10/456 (2.19%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Respiratory, thoracic and mediastinal disorders                 
Pulmonary: Other * 1  3/316 (0.95%)  10/456 (2.19%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Airway Obstruction - Larynx * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Airway Obstruction - Bronchus * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Nasal/Paranasal Reactions * 1  8/316 (2.53%)  50/456 (10.96%)  1/33 (3.03%)  7/165 (4.24%)  1/6 (16.67%)  1/34 (2.94%)  0/5 (0.00%)  2/37 (5.41%) 
Edema, Larynx * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Bronchospasm * 1  3/316 (0.95%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Aspiration * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Voice Changes * 1  6/316 (1.90%)  55/456 (12.06%)  0/33 (0.00%)  8/165 (4.85%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Cough * 1  53/316 (16.77%)  110/456 (24.12%)  5/33 (15.15%)  14/165 (8.48%)  1/6 (16.67%)  2/34 (5.88%)  0/5 (0.00%)  1/37 (2.70%) 
Pneumonitis * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pleural Effusion * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Dyspnea * 1  80/316 (25.32%)  110/456 (24.12%)  4/33 (12.12%)  15/165 (9.09%)  2/6 (33.33%)  1/34 (2.94%)  1/5 (20.00%)  2/37 (5.41%) 
Skin and subcutaneous tissue disorders                 
Nail Changes * 1  9/316 (2.85%)  39/456 (8.55%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Injection Site Reaction * 1  3/316 (0.95%)  9/456 (1.97%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hair Loss/Alopecia (Scalp Or Body) * 1  245/316 (77.53%)  289/456 (63.38%)  21/33 (63.64%)  47/165 (28.48%)  2/6 (33.33%)  3/34 (8.82%)  1/5 (20.00%)  2/37 (5.41%) 
Erythema Multiforme * 1  1/316 (0.32%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Cheilitis * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Wound Complication, Non-Infectious * 1  0/316 (0.00%)  8/456 (1.75%)  2/33 (6.06%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  1/5 (20.00%)  1/37 (2.70%) 
Bruising * 1  11/316 (3.48%)  15/456 (3.29%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Acne * 1  2/316 (0.63%)  9/456 (1.97%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Rash * 1  49/316 (15.51%)  87/456 (19.08%)  4/33 (12.12%)  10/165 (6.06%)  0/6 (0.00%)  3/34 (8.82%)  1/5 (20.00%)  2/37 (5.41%) 
Dry Skin * 1  5/316 (1.58%)  25/456 (5.48%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  1/37 (2.70%) 
Decubitus * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Telangiectasia * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Pruritus * 1  25/316 (7.91%)  46/456 (10.09%)  2/33 (6.06%)  10/165 (6.06%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Burn * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Urticaria * 1  5/316 (1.58%)  23/456 (5.04%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Flushing * 1  11/316 (3.48%)  21/456 (4.61%)  1/33 (3.03%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hand-Foot * 1  2/316 (0.63%)  5/456 (1.10%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Dermatology/Skin - Other * 1  10/316 (3.16%)  23/456 (5.04%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hyperpigmentation * 1  1/316 (0.32%)  10/456 (2.19%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ulceration * 1  1/316 (0.32%)  9/456 (1.97%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  1/37 (2.70%) 
Vascular disorders                 
Inr * 1  1/316 (0.32%)  9/456 (1.97%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Dic * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Thrombotic Microangiopathy * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Ptt * 1  1/316 (0.32%)  7/456 (1.54%)  1/33 (3.03%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gu - Urinary Nos * 1  0/316 (0.00%)  5/456 (1.10%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gu - Vagina * 1  8/316 (2.53%)  9/456 (1.97%)  1/33 (3.03%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gu - Urethra * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage/Pulmonary - Lung * 1  1/316 (0.32%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gi - Rectum * 1  6/316 (1.90%)  19/456 (4.17%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage/Pulmonary - Respiratory Tract Nos * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gi - Stoma * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gi - Varices (Rectal) * 1  1/316 (0.32%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage/Pulmonary - Nose * 1  8/316 (2.53%)  116/456 (25.44%)  0/33 (0.00%)  13/165 (7.88%)  0/6 (0.00%)  3/34 (8.82%)  0/5 (0.00%)  0/37 (0.00%) 
Hematoma * 1  1/316 (0.32%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gi - Anus * 1  0/316 (0.00%)  6/456 (1.32%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gu - Ureter * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gi - Lower Gi Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gi - Oral Cavity * 1  2/316 (0.63%)  17/456 (3.73%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gu - Bladder * 1  1/316 (0.32%)  2/456 (0.44%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gi - Stomach * 1  1/316 (0.32%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage, Gi - Colon * 1  0/316 (0.00%)  3/456 (0.66%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Petechiae * 1  0/316 (0.00%)  4/456 (0.88%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Hemorrhage/Bleeding - Other * 1  1/316 (0.32%)  3/456 (0.66%)  0/33 (0.00%)  3/165 (1.82%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Vascular - Other * 1  0/316 (0.00%)  2/456 (0.44%)  0/33 (0.00%)  1/165 (0.61%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Visceral Arterial Ischemia * 1  0/316 (0.00%)  0/456 (0.00%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Vein Injury - Extremity-Lower * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Artery Injury - Other Nos * 1  0/316 (0.00%)  1/456 (0.22%)  0/33 (0.00%)  0/165 (0.00%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Thrombosis/Embolism (Vascular Access-Related) * 1  1/316 (0.32%)  3/456 (0.66%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  1/34 (2.94%)  0/5 (0.00%)  0/37 (0.00%) 
Thrombosis/Thrombus/Embolism * 1  0/316 (0.00%)  11/456 (2.41%)  0/33 (0.00%)  2/165 (1.21%)  0/6 (0.00%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
Phlebitis * 1  1/316 (0.32%)  5/456 (1.10%)  0/33 (0.00%)  1/165 (0.61%)  1/6 (16.67%)  0/34 (0.00%)  0/5 (0.00%)  0/37 (0.00%) 
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Christopher Purdy on behalf of Austin Miller PhD
Organization: NRG Oncology
Phone: (716) 845-1300 ext 2296
EMail: purdyc@nrgoncology.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00565851    
Other Study ID Numbers: NCI-2009-00587
NCI-2009-00587 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
09-0205
GOG-0213
CDR0000546714
GOG-0213 ( Other Identifier: NRG Oncology )
GOG-0213 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: November 29, 2007
First Posted: November 30, 2007
Results First Submitted: November 13, 2020
Results First Posted: December 14, 2020
Last Update Posted: May 7, 2024