Trial Outcomes & Findings for Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (NCT NCT00951496)
NCT ID: NCT00951496
Last Updated: 2021-05-04
Results Overview
Estimate the median duration of progression-free survival in months. Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1560 participants
Primary outcome timeframe
Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.
Results posted on
2021-05-04
Participant Flow
The study was opened for accrual on July 27, 2009. Target accrual was about 1500 patients. The study was closed to enrollment on Nov 30, 2011 after enrolling 1560 individuals.
Eligibility was verified by a web-based procedure which reviewed all eligibility criteria prior to each subject's registration. Prior to treatment randomization patients were stratified by stage of disease and size of residual disease.
Participant milestones
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Overall Study
STARTED
|
521
|
518
|
521
|
|
Overall Study
COMPLETED
|
511
|
510
|
508
|
|
Overall Study
NOT COMPLETED
|
10
|
8
|
13
|
Reasons for withdrawal
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Overall Study
Did not initiate study treatment
|
10
|
8
|
13
|
Baseline Characteristics
Bevacizumab and Intravenous or Intraperitoneal Chemotherapy in Treating Patients With Stage II-III Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
n=521 Participants
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
n=518 Participants
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
n=521 Participants
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
Total
n=1560 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<40 years
|
27 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Age, Customized
40 - 49 years
|
101 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
273 Participants
n=4 Participants
|
|
Age, Customized
50 - 59 years
|
187 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
564 Participants
n=4 Participants
|
|
Age, Customized
60 -69 years
|
152 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
484 Participants
n=4 Participants
|
|
Age, Customized
70 - 79 years
|
51 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Age, Customized
>79 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
521 Participants
n=5 Participants
|
518 Participants
n=7 Participants
|
521 Participants
n=5 Participants
|
1560 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
473 Participants
n=5 Participants
|
478 Participants
n=7 Participants
|
476 Participants
n=5 Participants
|
1427 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
FIGO Stage FIGO (International Federation of Gynecology & Obstetrics) Staging
Stage I-II
|
56 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
163 Participants
n=4 Participants
|
|
FIGO Stage FIGO (International Federation of Gynecology & Obstetrics) Staging
Stage III
|
441 Participants
n=5 Participants
|
432 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
1305 Participants
n=4 Participants
|
|
FIGO Stage FIGO (International Federation of Gynecology & Obstetrics) Staging
Stage IV
|
24 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
|
Residual Disease Diameter
Microscopic only
|
297 Participants
n=5 Participants
|
297 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
899 Participants
n=4 Participants
|
|
Residual Disease Diameter
0 < diameter <= 1cm
|
182 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
553 Participants
n=4 Participants
|
|
Residual Disease Diameter
> 1cm
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
108 Participants
n=4 Participants
|
|
Histology/Grade of tumor
Serous/Grade1
|
20 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
|
Histology/Grade of tumor
Serous/Grade 2
|
43 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
114 Participants
n=4 Participants
|
|
Histology/Grade of tumor
Serous/Grade 3
|
370 Participants
n=5 Participants
|
379 Participants
n=7 Participants
|
377 Participants
n=5 Participants
|
1126 Participants
n=4 Participants
|
|
Histology/Grade of tumor
Endometrioid
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Histology/Grade of tumor
Clear Cell
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Histology/Grade of tumor
Mucinous
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Histology/Grade of tumor
Other/Not specified
|
48 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Progression-free survival is measured from date of randomization until first indication of progression based on RECIST criteria or death from any cause, or if progression-free at last contact, the date of last disease assessment up to 10 years.Population: Intention-to-treat: All enrolled patients
Estimate the median duration of progression-free survival in months. Progression is defined using Response Evaluation Criteria in Solid Tumors criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
n=521 Participants
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
n=518 Participants
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
n=521 Participants
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Median Progression-free Survival
|
24.9 months
Interval 22.3 to 27.2
|
27.3 months
Interval 24.6 to 28.8
|
26.0 months
Interval 23.8 to 28.0
|
SECONDARY outcome
Timeframe: During treatment and up to 30 days after end of treatmentPopulation: Treated Patients
Eligible and treated patients. CTCAE includes grades 1-5. Grade refers to the severity of the adverse event. Grades 0 listed should be interpreted to mean there were no subjects in the arm with a toxicity to report. Grade 1 toxicities are mild; asymptomatic or mild symptoms. Grade 2 toxicities are moderate; minimal, local or noninvasive intervention indicated. Grade 3 toxicities are severe or medically significant but not immediately life-threatening. Grade 4 toxicities are life threatening. Grade 5 is death related to adverse event.
Outcome measures
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
n=521 Participants
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
n=518 Participants
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
n=521 Participants
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0
Adverse Event Grade 0
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0
Adverse Event Grade 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0
Adverse Event Grade 2
|
48 Participants
|
46 Participants
|
52 Participants
|
|
Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0
Adverse Event Grade 3
|
269 Participants
|
300 Participants
|
246 Participants
|
|
Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0
Adverse Event Grade 4
|
185 Participants
|
158 Participants
|
199 Participants
|
|
Patients With Adverse Events by Treatment Group, as Defined by NCI CTCAE (Common Terminology Criteria for Adverse Events Version 3.0) Version 3.0
Adverse Event Grade 5
|
8 Participants
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Up to 10 yearsPopulation: Intention-to-treat: All enrolled patients
Estimate the median duration of overall survival in months.
Outcome measures
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
n=521 Participants
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
n=518 Participants
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
n=521 Participants
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Overall Survival
|
75.4 Months
Interval 67.1 to
Not defined because there are insufficient number of participant with event.
|
74.2 Months
Interval 61.9 to 78.4
|
67.6 Months
Interval 63.5 to 74.6
|
SECONDARY outcome
Timeframe: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, up to 84 weeks post starting treatmentPopulation: Patients evaluable for PRO (Patient Reported Outcomes)/QOL (completed baseline and at least one follow-up assessment)
QOL was measured with the FACT-O TOI score. Means at baseline are raw means. Scores are reported at all time points in the outcome measure table. FACT-O TOI is Trial outcome index (TOI) of the Functional assessment of cancer therapy (FACT) for ovarian cancer (FACT-O). The FACT-O TOI is composed of three subscales; Physical Well Being (PWB) ( 7 items), and Ovarian Cancer subscale (OCS) (12 items). Each item in the FACT-O TOI are scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much). A subscale score is computed as long as more thatn 50% of subscale items have been answered. A total score of the FACT-O items provide valid responses and all three subscales have valid scores. A score of the FACT-) TOI is ranged 0-104 with a larger score indicating a more preferred state of health-related quality of life (HRQOL).
Outcome measures
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
n=492 Participants
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
n=481 Participants
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
n=464 Participants
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Patient Reported Quality of Life (QOL)
Baseline
|
68.5 Units on a scale
Standard Error 0.7
|
67.4 Units on a scale
Standard Error 0.7
|
67.7 Units on a scale
Standard Error 0.7
|
|
Patient Reported Quality of Life (QOL)
Prior to cycle 4
|
67.8 Units on a scale
Standard Error 0.6
|
65.6 Units on a scale
Standard Error 0.6
|
61.9 Units on a scale
Standard Error 0.6
|
|
Patient Reported Quality of Life (QOL)
Prior to cycle 7
|
69.1 Units on a scale
Standard Error 0.6
|
68.2 Units on a scale
Standard Error 0.6
|
65.7 Units on a scale
Standard Error 0.7
|
|
Patient Reported Quality of Life (QOL)
Prior to cycle 13
|
77.3 Units on a scale
Standard Error 0.6
|
77.1 Units on a scale
Standard Error 0.6
|
78.4 Units on a scale
Standard Error 0.6
|
|
Patient Reported Quality of Life (QOL)
Prior to cycle 21
|
77.7 Units on a scale
Standard Error 0.6
|
76.9 Units on a scale
Standard Error 0.7
|
78.2 Units on a scale
Standard Error 0.6
|
|
Patient Reported Quality of Life (QOL)
84 weeks
|
78.3 Units on a scale
Standard Error 0.7
|
77.7 Units on a scale
Standard Error 0.7
|
79.4 Units on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatmentPopulation: Patients evaluable for PRO(Patient Reported Outcome)/QOL (completed baseline and at least one follow-up assessment).
The FACT/GOG-NTX subscale (short version) contains 4 items measuring sensory neuropathy. Each item is scored using a 5 point Likert scale (0=not at all; 1=a little bit;2=somewhat;3=quite a bit; 4=very much). For each item, reversal was performed prior to score calculation so that a large score suggests less symptoms. According to the FACIT measurement system, the subscale score was calculated as the summation of the individual item scores if more than 50% of a subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the subscale. The Ntx subscale score ranges from 0-16 with a large subscale score suggesting less symptom or better QOL.
Outcome measures
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
n=492 Participants
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
n=481 Participants
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
n=464 Participants
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Patient Reported Neurotoxicity (Ntx)
Baseline
|
15.4 Units on a scale
Standard Error 0.1
|
15.4 Units on a scale
Standard Error 0.1
|
15.4 Units on a scale
Standard Error 0.1
|
|
Patient Reported Neurotoxicity (Ntx)
Prior to cycle 4
|
12.9 Units on a scale
Standard Error 0.2
|
13.0 Units on a scale
Standard Error 0.2
|
13.6 Units on a scale
Standard Error 0.2
|
|
Patient Reported Neurotoxicity (Ntx)
Prior to cycle 7
|
10.4 Units on a scale
Standard Error 0.2
|
10.3 Units on a scale
Standard Error 0.2
|
10.9 Units on a scale
Standard Error 0.2
|
|
Patient Reported Neurotoxicity (Ntx)
Prior to cycle 13
|
11.1 Units on a scale
Standard Error 0.2
|
10.5 Units on a scale
Standard Error 0.2
|
9.2 Units on a scale
Standard Error 0.2
|
|
Patient Reported Neurotoxicity (Ntx)
Prior to cycle 21
|
11.4 Units on a scale
Standard Error 0.2
|
11.1 Units on a scale
Standard Error 0.2
|
11.0 Units on a scale
Standard Error 0.2
|
|
Patient Reported Neurotoxicity (Ntx)
84 weeks
|
11.9 Units on a scale
Standard Error 0.2
|
11.4 Units on a scale
Standard Error 0.2
|
11.5 Units on a scale
Standard Error 0.2
|
SECONDARY outcome
Timeframe: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatmentPopulation: Patients evaluable for PRO (Patient Reported Outcomes)/QOL. Evaluable patients have completed baseline and at least one follow-up assessment.
Patient reported fatigue as measured with the Functional Assessment of Chronic Illness Therapy- Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue contains 13 items. Each item was scored using a 5-point scale (0=not at all; 1=a little bit; 2=somewhat; 3=quite a bit; 4=very much). For the negative items, reversal was performed prior to score calculation. According to the FACIT measurement system, the Fatigue score was the summation of the individual item scores if more than 50% of subscale items were answered. When unanswered items existed, a subscale score was prorated by multiplying the mean of the answered item scores by the number of items in the scale. The FACIT-Fatigue score ranges 0-52 with a large score suggesting less fatigue.
Outcome measures
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
n=492 Participants
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
n=481 Participants
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
n=464 Participants
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Patient Reported Fatigue
Prior to cycle 13
|
35.7 units on a scale
Standard Error 0.3
|
35.5 units on a scale
Standard Error 0.3
|
35.9 units on a scale
Standard Error 0.3
|
|
Patient Reported Fatigue
Prior to cycle 21
|
35.5 units on a scale
Standard Error 0.3
|
35.1 units on a scale
Standard Error 0.3
|
36.3 units on a scale
Standard Error 0.3
|
|
Patient Reported Fatigue
84 weeks
|
35.7 units on a scale
Standard Error 0.3
|
36.0 units on a scale
Standard Error 0.3
|
36.5 units on a scale
Standard Error 0.3
|
|
Patient Reported Fatigue
Baseline
|
35.3 units on a scale
Standard Error 0.3
|
35.1 units on a scale
Standard Error 0.3
|
35.3 units on a scale
Standard Error 0.3
|
|
Patient Reported Fatigue
Prior to cycle 4
|
32.5 units on a scale
Standard Error 0.3
|
32.0 units on a scale
Standard Error 0.3
|
31.3 units on a scale
Standard Error 0.3
|
|
Patient Reported Fatigue
Prior to cycle 7
|
32.7 units on a scale
Standard Error 0.3
|
32.7 units on a scale
Standard Error 0.3
|
32.4 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Time points: Baseline, prior to cycle 4, prior to cycle 7, prior to cycle 13, prior to cycle 21, 84 weeks post starting treatmentPopulation: Patients evaluable for PRO (Patient Reported Outcomes)/QOL are patients who completed baseline and at least one follow-up assessment
Nausea was measured with the a single item ,' I have nausea' from the FACT-O TOI, and was scored using a 5 point scale (0=not at all; 1=a little bit; 2=somewhat;3=quite a bit;4=very much)
Outcome measures
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
n=492 Participants
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
n=481 Participants
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
n=464 Participants
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Patient Reported Nausea
Baseline
|
0.4 units on a scale
Standard Error 0.04
|
0.4 units on a scale
Standard Error 0.04
|
0.4 units on a scale
Standard Error 0.04
|
|
Patient Reported Nausea
Prior to cycle 4
|
0.6 units on a scale
Standard Error 0.04
|
0.7 units on a scale
Standard Error 0.04
|
1.1 units on a scale
Standard Error 0.05
|
|
Patient Reported Nausea
Prior to cycle 7
|
0.5 units on a scale
Standard Error 0.04
|
0.5 units on a scale
Standard Error 0.04
|
0.7 units on a scale
Standard Error 0.05
|
|
Patient Reported Nausea
Prior to cycle 13
|
0.2 units on a scale
Standard Error 0.03
|
0.3 units on a scale
Standard Error 0.03
|
0.2 units on a scale
Standard Error 0.03
|
|
Patient Reported Nausea
Prior to cycle 21
|
0.3 units on a scale
Standard Error 0.04
|
0.4 units on a scale
Standard Error 0.04
|
0.3 units on a scale
Standard Error 0.03
|
|
Patient Reported Nausea
84 Weeks
|
0.3 units on a scale
Standard Error 0.04
|
0.4 units on a scale
Standard Error 0.04
|
0.3 units on a scale
Standard Error 0.03
|
Adverse Events
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
Serious events: 156 serious events
Other events: 511 other events
Deaths: 0 deaths
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
Serious events: 179 serious events
Other events: 510 other events
Deaths: 0 deaths
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
Serious events: 215 serious events
Other events: 507 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
n=511 participants at risk
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
n=510 participants at risk
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
n=508 participants at risk
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Neutrophils
|
2.0%
10/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Platelets
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytes
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Sinus/Node (S/N) Arrhythmia: Atrial Fibrillation
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Right Ventricular Dysfunction
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Hypertension
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Restrictive Cardiomyopathy
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Left Venticular Diastolic Dysfunction
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Cardiac General - Other
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
International Normalized ratio (Inr)
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Fever
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Weight Loss
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Rigors/Chills
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Fatigue
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Death No Ctcae Term - Disease Progression Not otherwise specified (NOS)
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Death No Ctcae Term - Death Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Death No Ctcae Term - Multi-Organ Failure
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Death No Ctcae Term - Sudden Death
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Wound Complication, Non-Infectious
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Colon/Cecum/Appendix
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Perforation, Gastrointestinal (GI) - Duodenum
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Perforation, Gi - Appendix
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Ileum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Necrosis, Gi - Small Bowel Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Perforation, Gi - Colon
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Small Bowel Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Leak, Gi - Large Bowel
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Leak, Gi - Leak Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Anus
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Distention
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Abdomen Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Gallbladder
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Duodenal
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
3.3%
17/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.9%
20/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Jejunum
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Perforation, Gi - Small Bowel Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.6%
13/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Dehydration
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Perforation, Gi - Ileum
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Genitourinary (Gu) - Urinary Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Peritoneal Cavity
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Upper Gi Nos
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage With Surgery
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hematoma
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Lower Gi Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Stomach
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Colon
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Cns
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Hepatobiliary disorders
Hepatobiliary/Pancreas - Other
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Hepatobiliary disorders
Pancreatitis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Infection (Inf) with Grade 3 Or 4 Absolute Neutrophil Count (Anc): Wound
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Colon
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Anal/Perianal
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Mediastinum Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Gallbladder
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Appendix
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Febrile Neutropenia
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Lung (Pneumonia)
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Colon
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Blood
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Infection - Other
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Colitis, Infectious (Eg.C. Difficile)
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Abdomen Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Up. Aerodigestive
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Catheter-Related
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Rectum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Abdomen Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia)
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Catheter-Related
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Lymphocele
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Proteinuria
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Creatinine
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Alanine Aminotransferase (Alt)
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Seroma
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Device/Prosthesis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Syncope
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Neurology - Other
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Speech Impairment
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Seizure
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Personality
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Cognitive Disturbance
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Central Nervous System (Cns) Ischemia
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Confusion
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Memory Impairment
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Neuropathy-Sensory
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Blurred Vision
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain - Other
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Chest /Thorax Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Head/Headache
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Neck
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Joint
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Bladder
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Oral Cavity
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Esophagus
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Abdominal Pain Nos
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.5%
13/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Cardiac/ Heart
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Perforation, Gu - Vagina
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Leak, Gu - Vagina
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Urinary Color Change
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Fistula, Gu - Vagina
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Fistula, Gu - Bladder
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2nd Malignancy: Poss. Related To Cancer Rx
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Syndromes - Other
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
4.9%
25/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.9%
25/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.9%
25/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
Other adverse events
| Measure |
Arm I (Paclitaxel, Carboplatin, Bevcizumab IV)
n=511 participants at risk
Six cycles of Paclitaxel 80mg/m2 IV over ' hours days 1, 8 and 15. Carboplatin AUC 6 IV on day 1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2, followed by bevacizumab 15mg/kg for cycles 7-22.
|
Arm II (Paclitaxel,carboplatinIP, Bevacizumab IP)
n=510 participants at risk
Six cycles of Paclitaxel 80mg/m2 IV over 1 hour days 1, 8, and 15, Carboplatin AUC 6 IP on day1, Bevacizumab 15mg/kg IV on day 1 beginning on cycle 2 followed by bevacizumab 15mg/KG for cycles 7-22
|
Arm III (Paclitaxel IP, Cisplatin, Bevacizumab)
n=508 participants at risk
Six cycles of Paclitaxel 135 mg/m2 IV over 3 hours day 1, Cisplatin 75 mg/m2 IP on day 2, Paclitaxel 60 mg/m2 IP on day 8, Bevacizumab 15 mg/kg IV on day 1 beginning with cycle 2, followed by bevacizumab 15 mg/kg for cycles 7-22.
|
|---|---|---|---|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Colon
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Anal/Perianal
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Ungual (Nails)
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Lower
|
3.9%
20/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.9%
30/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.3%
17/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Syncope
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.7%
24/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Upper Gi Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Nose
|
51.1%
261/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
45.3%
231/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
36.2%
184/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hematoma
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.6%
8/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Anus
|
1.6%
8/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Esophagus
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gu - Ureter
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Duodenum
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Lower Gi Nos
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Oral Cavity
|
7.4%
38/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.3%
32/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.1%
26/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gu - Kidney
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gu - Bladder
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Stomach
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Colon
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Cns
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Petechiae
|
1.8%
9/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Hepatobiliary disorders
Liver Dysfunction
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Hepatobiliary disorders
Pancreatitis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Wound
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Blood
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Immune system disorders
Allergy/Immunology - Other
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Immune system disorders
Allergic Reaction/Hypersensitivity
|
7.0%
36/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
10.0%
51/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
10.6%
54/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Immune system disorders
Vasculitis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Immune system disorders
Rhinitis
|
27.6%
141/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
23.3%
119/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
20.3%
103/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Immune system disorders
Autoimmune Reaction
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Ear and labyrinth disorders
Otitis Middle Ear
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Ear and labyrinth disorders
Auditory/Ear - Other
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Ear and labyrinth disorders
Otitis External Ear
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Ear and labyrinth disorders
Hearing (Without Monitoring Program)
|
2.3%
12/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.1%
21/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Ear and labyrinth disorders
Tinnitus
|
11.7%
60/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.5%
33/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
11.6%
59/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Ear and labyrinth disorders
Hearing (Monitoring Program)
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Neutrophils
|
94.7%
484/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
92.7%
473/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
90.9%
462/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Platelets
|
72.6%
371/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
72.5%
370/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
49.8%
253/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytes
|
95.1%
486/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
94.1%
480/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
90.4%
459/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.4%
48/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
10.8%
55/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
8.7%
44/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
97.7%
499/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
96.1%
490/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
95.1%
483/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Prolonged Q wave and tc wave Interval
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Fibrillation
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Conduction Abnml: Conduction Abnormality Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Palpitations
|
8.0%
41/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.9%
25/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.1%
31/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Conduction Abnml: Av Block 1st Degree
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Ventricular Arrhythmia - Tachycardia
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Tachycardia
|
5.1%
26/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.9%
20/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.0%
15/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Vasovagal Episode
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
S/N Arrhythmia: Sinus Bradycardia
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Ventricular Arrhythmia - Pvcs
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Ventricular Arrhythmia - Trigeminny
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Ventricular Arrhythmia - Bigeminy
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
S/N Arrhythmia: Atrial Tachycardia
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Cardiac Ischemia/Infarction
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Right Ventricular Dysfunction
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Pulmonary Hypertension
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Hypertension
|
40.1%
205/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
37.1%
189/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
47.6%
242/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Valvular Heart Disease
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Left Venticular Diastolic Dysfunction
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Lt Ventricular Systolic Dysfunction
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Cardiac General - Other
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Cardiac Troponin I (Ctni)
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Cardiac Troponin T (Ctnt)
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Pericardial Effusion
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Cardiac disorders
Hypotension
|
2.9%
15/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.7%
19/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.7%
29/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Inr
|
2.3%
12/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.1%
16/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Partial Throboplastin Time (Ptt)
|
2.0%
10/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Constitutional Symptoms - Other
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Sweating
|
4.9%
25/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.7%
19/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.5%
23/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Weight Gain
|
23.7%
121/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
20.6%
105/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
16.1%
82/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Patient Odor
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Fever
|
10.8%
55/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
13.3%
68/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
12.2%
62/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Weight Loss
|
12.5%
64/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
15.7%
80/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
19.1%
97/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Hypothermia
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Rigors/Chills
|
4.7%
24/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.1%
26/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
7.3%
37/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Fatigue
|
91.0%
465/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
89.6%
457/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
88.8%
451/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Insomnia
|
31.3%
160/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
29.6%
151/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
29.5%
150/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Death No Ctcae Term - Death Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
26.8%
137/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
22.2%
113/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
9.4%
48/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Injection Site Reaction
|
1.4%
7/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.7%
19/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Foreign Body
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia (Scalp Or Body)
|
78.7%
402/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
74.1%
378/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
74.2%
377/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis - Chemoradiation
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Induration
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Wound Complication, Non-Infectious
|
6.7%
34/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
8.4%
43/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
9.1%
46/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
8.4%
43/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
9.6%
49/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.1%
31/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.5%
13/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.1%
16/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
36.4%
186/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
37.6%
192/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
23.8%
121/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
11.9%
61/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
10.0%
51/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.7%
29/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Atrophy, Skin
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.4%
43/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
7.6%
39/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
7.1%
36/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Burn
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
5.9%
30/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.1%
26/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.9%
25/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
2.5%
13/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
3.3%
17/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.7%
24/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
2.9%
15/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.9%
20/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.6%
8/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
1.6%
8/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.5%
13/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Endocrine disorders
Hot Flashes
|
20.2%
103/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
16.5%
84/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
17.5%
89/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Endocrine disorders
Diabetes
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Endocrine disorders
Hypoparathyroidism
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Endocrine disorders
Endocrine - Other
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
1.4%
7/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Endocrine disorders
Cushingoid
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Colon/Cecum/Appendix
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Perforation, Gi - Duodenum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Ulcer,gi - Colon
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Ileum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Proctitis
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Ulcer,gi - Anus
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Salivary Gland Changes
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
4.7%
24/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.3%
22/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.1%
26/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Perforation, Gi - Colon
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Ulcer,gi - Duodenum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Ileum
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Dental: Periodontal
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Small Bowel Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Rectum
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Dental-Tooth
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Colon
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
9/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Ulcer,gi - Stoma
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Esophagitis
|
1.4%
7/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Hemorrhoids
|
8.8%
45/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
7.5%
38/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.7%
24/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Heartburn
|
19.0%
97/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
15.7%
80/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
21.1%
107/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Ulcer,gi - Stomach
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Dental: Teeth
|
2.2%
11/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Pharynx
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Jejunum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Anus
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Leak, Gi - Rectum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Dental: Teeth Development
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
23/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.5%
23/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.1%
21/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Distention
|
9.2%
47/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
12.4%
63/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
18.3%
93/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Taste Alteration
|
22.9%
117/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
19.6%
100/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
19.1%
97/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Incontinence, Anal
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Abdomen Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
4.3%
22/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.3%
17/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.0%
15/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Stomach
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Gallbladder
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Rectum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Oral Cavity
|
17.4%
89/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
15.7%
80/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
9.4%
48/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Stricture, Gi - Colon
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Obstruction, Gi - Small Bowel Nos
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Fistula, Gi - Oral Cavity
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Stomach
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Functional/Sympt) - Anus
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Perforation, Gi - Small Bowel Nos
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Oral Cavity
|
22.9%
117/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
21.0%
107/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
15.0%
76/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Larynx
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Esophagus
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
30.9%
158/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
31.4%
160/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
42.3%
215/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Anorexia
|
31.5%
161/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
31.2%
159/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
41.5%
211/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Dehydration
|
5.1%
26/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
10.2%
52/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
18.3%
93/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
62.8%
321/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
63.3%
323/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
65.9%
335/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Stricture, Gi - Small Bowel Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
62.0%
317/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
64.9%
331/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
77.4%
393/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Malabsorption
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
2.2%
11/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Perforation, Gi - Ileum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Leak, Gi - Stomach
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
43.8%
224/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
51.6%
263/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
52.0%
264/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Prolapse Of Stoma, Gi
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Mucositis (Clinical Exam) - Pharynx
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Gastrointestinal disorders
Perforation, Gi - Jejunum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gu - Stoma
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gu - Urinary Nos
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gu - Vagina
|
3.1%
16/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.1%
21/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Bronchopulmonary Nos
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Lung
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Pharynx
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Rectum
|
7.0%
36/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.5%
23/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.0%
15/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage/Pulmonary - Respiratory Tract Nos
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Stoma
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Varices (Rectal)
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Hemorrhage, Gi - Peritoneal Cavity
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Skin (Cellulitis)
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Middle Ear
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: External Ear
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vulva
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Upper Airway Nos
|
4.7%
24/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.3%
32/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.5%
28/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Paranasal
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Nose
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Neck Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Infection (Inf) With Normal Or Grade 1 Or 2 Absolute Neutrophil Count (Anc): Mediastinum Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia)
|
1.4%
7/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.6%
8/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Larynx
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Eye Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Peritoneal Cavity
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Small Bowel Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Esophagus
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Soft Tissue Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Joint
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.7%
24/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.5%
23/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.1%
31/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Biliary Tree
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urethra
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Blood
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Wound
|
1.8%
9/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.1%
16/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.3%
17/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Small Bowel Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Oral Cavity-Gums
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Otitis Media Nos
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis)
|
2.5%
13/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.3%
22/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.3%
17/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Catheter-Related
|
1.8%
9/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.6%
13/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Febrile Neutropenia
|
1.4%
7/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Lip/Perioral
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Rectum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Infection (Inf) Unknown Absolute Neutrophil Count (Anc): Lung (Pneumonia)
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Nose
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Sinus
|
3.1%
16/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Dental-Tooth
|
1.6%
8/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Colon
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Viral Hepatitis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Urinary Tract Nos
|
7.8%
40/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
8.2%
42/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
9.1%
46/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Abdomen Nos
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Ungual (Nails)
|
2.3%
12/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.5%
13/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Blood
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Stomach
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Stomach
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Infection - Other
|
3.1%
16/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Bladder (Urinary)
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Opportunisitic Inf Assoc. W/Gr 2 Lymphopenia
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Colitis, Infectious (Eg.C. Difficile)
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Nerve-Peripheral
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Oral Cavity-Gums
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Vulva
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Vagina
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bronchus
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.6%
8/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Abdomen Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Mucosa
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Pelvis Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Upper Airway Nos
|
2.3%
12/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Upper Aerodigestive
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pharynx
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Vagina
|
1.6%
8/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Sinus
|
4.9%
25/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.3%
27/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.5%
18/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Pelvis Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Pharynx
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Mucosa
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Bronchus
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Eye Nos
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Nerve-Cranial
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Soft Tissue Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc:peritoneal Cavity
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Urinary Tract Nos
|
3.1%
16/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.1%
26/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Urethra
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Bladder (Urinary)
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.7%
14/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Wound
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Foreign Body
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Catheter-Related
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Rectum
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Peritoneal Cavity
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Oral Cavity-Gums
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Foreign Body
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Dental-Tooth
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Colon
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Appendix
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Anal/Perianal
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Abdomen Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Skin (Cellulitis)
|
1.8%
9/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Lip/Perioral
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Middle Ear
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: External Ear
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Vagina
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Upper Airway Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Upper Aerodigestive
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Anal/Perianal
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Sinus
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Nose
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Mucosa
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Lung (Pneumonia)
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Eye Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Conjunctiva
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Kidney
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Ungual (Nails)
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Soft Tissue Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Lymphatic
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: Bladder
|
2.2%
11/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf Unknown Anc: Esophagus
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urinary Tract Nos
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Nml Or Gr 1 Or 2 Anc: External Ear
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Urethra
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Catheter-Related
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Infections and infestations
Inf W/Gr 3 Or 4 Anc: Kidney
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Lymphedema-Related Fibrosis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Lymphocele
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Edema: Trunk/Genital
|
1.6%
8/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Edema: Limb
|
19.8%
101/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
20.8%
106/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
18.5%
94/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Edema: Head And Neck
|
2.3%
12/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Blood and lymphatic system disorders
Dermal Change
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Ast
|
20.4%
104/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
18.6%
95/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
16.7%
85/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Gfr
|
1.4%
7/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.9%
20/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory - Other
|
3.7%
19/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.9%
15/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.5%
33/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Alkalosis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Cholesterol,serum High
|
5.5%
28/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.1%
16/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Proteinuria
|
12.1%
62/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
12.7%
65/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
11.8%
60/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hemoglobinuria
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Creatinine
|
8.4%
43/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.5%
33/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
26.0%
132/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
12.9%
66/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
14.5%
74/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
18.9%
96/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Whole Body/Generalized
|
9.0%
46/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
10.2%
52/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
14.0%
71/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Gamma-Glutamyl Transferase (Ggt)
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.6%
8/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Alanine Aminotransferases (Alt)
|
19.2%
98/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
21.4%
109/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
15.2%
77/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Alkaline Phosphatase
|
11.9%
61/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
16.9%
86/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
14.4%
73/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Bilirubin
|
3.5%
18/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.9%
20/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.6%
13/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Lipase
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.7%
14/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.3%
22/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
8.6%
44/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.3%
32/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
7.5%
38/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
19.0%
97/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
22.2%
113/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
27.8%
141/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Trunk
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
2.7%
14/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.7%
14/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Creatine Phosphokinase (Cpk)
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Bicarbonate, Serum-Low
|
2.0%
10/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Amylase
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
2.9%
15/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.5%
13/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
12.5%
64/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
14.1%
72/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
18.9%
96/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.5%
28/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.5%
28/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
9.6%
49/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
29.0%
148/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
28.0%
143/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
29.9%
152/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
14.5%
74/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
17.8%
91/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
24.6%
125/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Right-Sided
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.9%
30/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.5%
28/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.1%
31/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Left-Sided
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
6.1%
31/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
7.3%
37/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
8.9%
45/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
25.4%
130/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
37.3%
190/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
47.6%
242/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis-Deep Connective Tissue
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Seroma
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/St: Other
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.9%
15/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness - Extremity-Upper
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Device/Prosthesis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint-Function
|
3.7%
19/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.5%
23/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.0%
15/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
2.0%
10/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis-Cosmesis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Extremity-Upper (Function)
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Gait/Walking
|
1.6%
8/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Cervical Spine Rom
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Involuntary Movement
|
2.9%
15/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.9%
25/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Psychosis
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Myelitis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Neurology - Other
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Mental Status
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Laryngeal Nerve Dysfunction
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Encephalopathy
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Cns Necrosis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Mood Alteration - Euphoria
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Mood Alteration - Depression
|
22.5%
115/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
17.8%
91/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
19.3%
98/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Mood Alteration - Anxiety
|
21.7%
111/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
20.0%
102/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
24.0%
122/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Mood Alteration - Agitation
|
1.6%
8/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Tremor
|
2.3%
12/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.5%
13/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.1%
21/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Speech Impairment
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Seizure
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Personality
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Leukoencephalopathy
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Irritability
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Somnolence
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Cognitive Disturbance
|
2.7%
14/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Cns Ischemia
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Ataxia
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.6%
8/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Confusion
|
3.5%
18/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.0%
15/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Memory Impairment
|
7.4%
38/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.9%
35/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.9%
35/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Dizziness
|
22.1%
113/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
21.0%
107/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
21.9%
111/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Neuropathy,cranial - Cn Viii Hearing/Balance
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Neuropathy,cranial - Cn Vii Motor-Face
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Neuropathy,cranial - Cn V Motor-Jaw Muscles
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Neuropathy,cranial - Cn Ii Vision
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Neuropathy,cranial - Cn I Smell
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Neuropathy-Sensory
|
79.5%
406/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
77.3%
394/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
80.1%
407/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Nervous system disorders
Neuropathy-Motor
|
9.4%
48/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
11.0%
56/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.9%
35/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Retinopathy
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Ocular/Visual - Other
|
1.8%
9/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Vitreous Hemorrhage
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Nystagmus
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Nyctalopia
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Watery Eye
|
5.1%
26/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.1%
26/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.6%
8/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Dry Eye
|
3.1%
16/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.5%
18/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Ocular Surface Disease
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Cataract
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Photophobia
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Flashing Lights/Floaters
|
3.5%
18/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.5%
23/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.3%
17/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Diplopia
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Blurred Vision
|
17.4%
89/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
16.1%
82/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
15.4%
78/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Keratitis
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Eye disorders
Eyelid Dysfunction
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain - Other
|
3.5%
18/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
8.0%
41/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.1%
31/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Urethra
|
2.7%
14/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.7%
29/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.8%
14/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Perineum
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Pelvis
|
4.1%
21/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
7.3%
37/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.5%
23/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Breast
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Vagina
|
2.3%
12/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Chest /Thorax Nos
|
8.6%
44/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
7.1%
36/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
6.5%
33/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Chest Wall
|
3.5%
18/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.3%
22/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.1%
21/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Throat/Pharynx/Larynx
|
10.6%
54/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
8.0%
41/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
7.1%
36/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Pleura
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Larynx
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Eye
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Head/Headache
|
45.8%
234/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
39.4%
201/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
41.1%
209/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Neck
|
7.8%
40/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
7.5%
38/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.9%
25/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Intestine
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Extremity-Limb
|
28.0%
143/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
26.1%
133/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
24.0%
122/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Buttock
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Back
|
23.5%
120/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
22.5%
115/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
20.1%
102/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Joint
|
46.0%
235/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
41.2%
210/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
39.2%
199/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Bone
|
9.4%
48/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
8.6%
44/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
8.1%
41/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Lymph Node
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Gallbladder
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Kidney
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Bladder
|
2.0%
10/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.9%
20/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Pain Nos
|
4.5%
23/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.1%
21/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.3%
22/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Stomach
|
2.7%
14/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.6%
8/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.2%
11/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Rectum
|
2.9%
15/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Peritoneum
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Oral Cavity
|
5.5%
28/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.5%
23/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.8%
14/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Esophagus
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Dental/Teeth/Peridontal
|
3.1%
16/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.6%
13/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Abdominal Pain Nos
|
47.6%
243/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
61.0%
311/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
68.1%
346/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Scalp
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Oral - Gums
|
2.2%
11/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.6%
8/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Skin
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Lip
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Middle Ear
|
3.1%
16/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: External Ear
|
1.6%
8/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Cardiac/ Heart
|
1.4%
7/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Face
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.78%
4/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Muscle
|
27.6%
141/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
24.9%
127/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
25.0%
127/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Anus
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Neuralgia
|
2.2%
11/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Pain: Sinus
|
1.8%
9/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary: Other
|
2.0%
10/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Airway Obstruction - Trachea
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Airway Obstruction - Bronchus
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
19.8%
101/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
15.9%
81/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
13.2%
67/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Edema, Larynx
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.2%
11/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
14.7%
75/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
11.2%
57/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
11.4%
58/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
10/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.0%
143/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
28.8%
147/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
22.8%
116/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Ards
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
1.8%
9/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
39.5%
202/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
39.8%
203/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
28.1%
143/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Stricture, Anastomotic, Gu - Ureter
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Prolapse Of Stoma, Gu
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Perforation, Gu - Vagina
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Leak, Gu - Vagina
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Leak, Gu - Bladder
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Cystitis
|
2.0%
10/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.9%
15/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Urinary Color Change
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Urinary Retention
|
1.2%
6/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.6%
8/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Urinary Electrolyte Wasting
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Obstruction, Gu - Ureter
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Obstruction, Gu - Bladder
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Incontinence, Urinary
|
7.4%
38/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.7%
19/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.3%
27/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Fistula, Gu - Vagina
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Fistula, Gu - Genital Tract-Female
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Fistula, Gu - Bladder
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Bladder Spasm
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Renal Failure
|
0.78%
4/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Renal and urinary disorders
Urinary Frequency
|
11.2%
57/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
12.4%
63/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
12.4%
63/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
2nd Mal: Poss. Related To Cancer Rx
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Reproductive system and breast disorders
Libido
|
2.3%
12/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Reproductive system and breast disorders
Irregular Menses
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Reproductive system and breast disorders
Vaginal Dryness
|
4.7%
24/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.7%
19/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Reproductive system and breast disorders
Sexual/Reproductive Function: Other
|
0.59%
3/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.79%
4/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Reproductive system and breast disorders
Vaginitis
|
1.4%
7/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.4%
7/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Reproductive system and breast disorders
Vaginal Mucositis
|
0.98%
5/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.39%
2/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
4.1%
21/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
3.7%
19/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
4.3%
22/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Surgical and medical procedures
Intra-Operative (Op) Injury: Nerves: Peripheral Motor Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Surgical and medical procedures
Intra-Op Injury: Teeth
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Surgical and medical procedures
Intra-Op Injury: Nasal Cavity
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Surgical and medical procedures
Intra-Op Injury: Kidney
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Surgical and medical procedures
Intra-Op Injury: Small Bowel Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Surgical and medical procedures
Intra-Op Injury: Peritoneal Cavity
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Surgical and medical procedures
Intra-Op Injury: Colon
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Surgical and medical procedures
Intra-Op Injury: Abdomen Nos
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Surgical and medical procedures
Intra-Op Injury: Adrenal Gland
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Syndromes - Other
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Cytokine Release Syndrome
|
0.39%
2/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.59%
3/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
General disorders
Flu-Like Syndrome
|
2.3%
12/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.8%
9/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.4%
12/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Vascular - Other
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Visceral Arterial Ischemia
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Vein Injury - Other Nos
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Peripheral Arterial Ischemia
|
0.00%
0/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.20%
1/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Vein Injury - Extremity-Lower
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.00%
0/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Thrombosis/Embolism (Vascular Access-Related)
|
1.4%
7/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
2.0%
10/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Thrombosis/Thrombus/Embolism
|
4.1%
21/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.3%
27/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
5.9%
30/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
|
Vascular disorders
Phlebitis
|
0.20%
1/511 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
1.2%
6/510 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
0.98%
5/508 • AEs were recorded from the initiation of any study treatment up until 30 days following the last cycle of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60